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| Product NDC Code | 69555-021 | ||||||||||
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| Drug Name | Stream2sea broad spectrum 20 - tinted |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LOTION | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | Stream2Sea, LLC | ||||||||||
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Titanium Dioxide 8.8%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours. For children under 6 months of age; ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.TINTED SPF 30 Deionized Water, Aqueous Extracts of Camellia Sinensis (Green Tea) Leaf*, Ociimum Tenuiflorum (Tulsi) Leaf*, Alara Ssculenta (Wakame Seaweed)* and Olea Europa (Olive) Leaf*, Caprylic Triglyceride, Aloe Barbadensis (Aloe) Leaf Juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhydroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Cocos Nucifera (Coconut) Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Iron Oxides (CI 77492, CI 77499) and Jojoba Ester *ORGANIC INGREDIENTS
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.Sunscreen.
Spl product data elements
Usually a list of ingredients in a drug product.Stream2Sea Broad Spectrum 30 Titanium Dioxide WATER GREEN TEA LEAF HOLY BASIL LEAF ALARIA ESCULENTA OLEA EUROPAEA LEAF MEDIUM-CHAIN TRIGLYCERIDES ALOE VERA LEAF COCO-GLYCERIDES GLYCERIN CETOSTEARYL ALCOHOL CETYL PALMITATE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN OLIVATE CETEARYL OLIVATE METHYLCELLULOSE, UNSPECIFIED COCONUT OIL STEARIC ACID LUVISET 360 MAGNESIUM ALUMINUM SILICATE SORBITAN MONOPALMITATE TOCOPHEROL XANTHAN GUM ALUMINUM OXIDE BENZYL ALCOHOL SALICYLIC ACID SORBIC ACID TITANIUM DIOXIDE TITANIUM DIOXIDE Stream2Sea Broad Spectrum 30 - Tinted Titanium Dioxide WATER GREEN TEA LEAF HOLY BASIL LEAF ALARIA ESCULENTA OLEA EUROPAEA LEAF MEDIUM-CHAIN TRIGLYCERIDES ALOE VERA LEAF COCO-GLYCERIDES GLYCERIN CETOSTEARYL ALCOHOL CETYL PALMITATE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN OLIVATE CETEARYL OLIVATE METHYLCELLULOSE, UNSPECIFIED COCONUT OIL STEARIC ACID LUVISET 360 MAGNESIUM ALUMINUM SILICATE SORBITAN MONOPALMITATE TOCOPHEROL XANTHAN GUM ALUMINUM OXIDE BENZYL ALCOHOL SALICYLIC ACID SORBIC ACID FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE JOJOBA OIL, RANDOMIZED TITANIUM DIOXIDE TITANIUM DIOXIDE Stream2Sea Broad Spectrum 20 Titanium Dioxide WATER GREEN TEA LEAF HOLY BASIL LEAF ALARIA ESCULENTA OLEA EUROPAEA LEAF MEDIUM-CHAIN TRIGLYCERIDES ALOE VERA LEAF COCO-GLYCERIDES GLYCERIN CETOSTEARYL ALCOHOL CETYL PALMITATE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN OLIVATE CETEARYL OLIVATE METHYLCELLULOSE, UNSPECIFIED COCONUT OIL STEARIC ACID LUVISET 360 MAGNESIUM ALUMINUM SILICATE SORBITAN MONOPALMITATE TOCOPHEROL XANTHAN GUM ALUMINUM OXIDE BENZYL ALCOHOL SALICYLIC ACID SORBIC ACID TITANIUM DIOXIDE TITANIUM DIOXIDE Stream2Sea Broad Spectrum 20 - Tinted Titanium Dioxide WATER GREEN TEA LEAF HOLY BASIL LEAF ALARIA ESCULENTA OLEA EUROPAEA LEAF MEDIUM-CHAIN TRIGLYCERIDES ALOE VERA LEAF COCO-GLYCERIDES GLYCERIN CETOSTEARYL ALCOHOL CETYL PALMITATE POLYHYDROXYSTEARIC ACID (2300 MW) SORBITAN OLIVATE CETEARYL OLIVATE METHYLCELLULOSE, UNSPECIFIED COCONUT OIL STEARIC ACID LUVISET 360 MAGNESIUM ALUMINUM SILICATE SORBITAN MONOPALMITATE TOCOPHEROL XANTHAN GUM ALUMINUM OXIDE BENZYL ALCOHOL SALICYLIC ACID SORBIC ACID FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE JOJOBA OIL, RANDOMIZED TITANIUM DIOXIDE TITANIUM DIOXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Stream2Sea Broad Spectrum Sport Face & Body SPF 20 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20 3oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20 32oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 2oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 3oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 32oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30 3oz Stream2Sea Water Spot SPF 30 -3 FL OZ (90 ML) Stream2Sea Broad Spectrum Sport Face & Body SPF 30 32oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30-TINTED 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30-TINTED 3oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30-TINTED 32oz Happy Ocean Water Sport SPF 30 (75 mL) Happy Ocean Water Sport SPF 30 Tinted (75 mL) Stream2Sea Broad Spectrum Sport Face & Body SPF 20 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20 3oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20 32oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 2oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 3oz Stream2Sea Broad Spectrum Sport Face & Body SPF 20-TINTED 32oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30 3oz Stream2Sea Water Spot SPF 30 -3 FL OZ (90 ML) Stream2Sea Broad Spectrum Sport Face & Body SPF 30 32oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30-TINTED 1oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30-TINTED 3oz Stream2Sea Broad Spectrum Sport Face & Body SPF 30-TINTED 32oz Label Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. RInse with water to remove.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API