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| Product NDC Code | 79265-8068 | ||||
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| Drug Name | Spf 50 tinted face mineral fragrance free sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | part352 | ||||
| Labeler Name | Babo Botanicals, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Zinc Oxide 20.2115%
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 DIRECTIONS Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS ARGANIA SPINOSA KERNEL EXTRACT, BEESWAX*, BISABOLOL*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COFFEA ARABICA (COFFEE) SEED EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, IRON OXIDES, JOJOBA ESTERS, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, OCTYLDODECANOL, OCTYLDODECYL OLEATE, ORYZANOL, ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, PUERARIA LOBATA ROOT EXTRACT*, ROSA CANINA FRUIT EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, TRIHYDROXYSTEARIN. *CERTIFIED ORGANIC INGREDIENT
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.USES Uses • Helps prevent sunburn | If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.PURPOSE SUNSCREEN
Spl product data elements
Usually a list of ingredients in a drug product.SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Mineral Sunscreen FERRIC OXIDE RED PUERARIA MONTANA VAR. LOBATA ROOT FILIPENDULA ULMARIA FLOWER HIPPOPHAE RHAMNOIDES FRUIT SUNFLOWER OIL TRIHYDROXYSTEARIN HYDROGENATED JOJOBA OIL, RANDOMIZED NASTURTIUM OFFICINALE FLOWERING TOP ROSA CANINA FRUIT JOJOBA OIL COCOA BUTTER ARGANIA SPINOSA SEED TOCOPHEROL AVOCADO OIL RICE BRAN OIL CANDELILLA WAX ARABICA COFFEE BEAN OCTYLDODECYL OLEATE CALENDULA OFFICINALIS FLOWER SHEA BUTTER CALOPHYLLUM TACAMAHACA SEED OIL CHAMOMILE ZINC OXIDE ZINC OXIDE WHITE WAX LEVOMENOL OCTYLDODECANOL ORYZANOL
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.Principal Display Panel 0.6 oz. 17 g 79265-8068-0 Outer Package Box
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.79265-8068-0 SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.
Primary Container Label 79265-8068-1 Primary container labeling
DRUG FACTS PANEL 79265-8068-0 Drug Facts Panel Drug Facts Panel 2
QUESTIONS / COMMENTS? Questions and comments: Call 1-877-537-BABO
INFORMATION PANEL 79265-8068-0 INFORMATION PANEL INFORMATION PANEL
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT USE Do not use on damaged or broken skin
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.KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Protect this product from excessive heat and direct sun.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.STOP USE AND ASK A DOCTOR Stop use and ask doctor if rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT When using this product Keep out of eyes. Rinse with water to remove
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 Warnings • For external use only. | Do not use on damaged or broken skin. | When using this product Keep out of eyes. Rinse with water to remove. | Stop use and ask doctor if rash occurs. | Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away
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