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| Product NDC Code | 75936-225 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Play lip balm with acai broad spectrum spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | STICK | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Supergoop, LLC | ||||||||
| 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 Purpose Avobenozone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen
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 generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: • limit your time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Hydrogenated Polyisobutene, Polyisobutene, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C18-38 Alkyl Hydroxystearoyl Stearate, Ozokerite, Cetyl Alcohol, Diethylhexyl 2,6-Naphthalate, Glyceryl Stearate, Polyglyceryl-10 Decaoleate, Carthamus Tinctorius (Safflower) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Trihydroxystearin, Helianthus Annuus (Sunflower) Seed Oil, Stevioside, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Tocopherol, Glycine Soja (Soybean) Oil, Euterpe Oleracea Fruit Extract, Ethyl Acetate, Gamma-Undecalactone, Vanilin
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.Stop use and ask a doctor if rash occurs.
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Play Lip Balm with Acai Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene ETHYL ACETATE SHEANUT BUTYLOCTYL SALICYLATE GLYCERYL MONOSTEARATE SAFFLOWER OIL SESAME OIL .GAMMA.-UNDECALACTONE 2-METHYLBUTYRIC ACID ACAI AGATHOSMA BETULINA LEAF OIL VANILLIN HYDROGENATED POLYBUTENE (1300 MW) CERESIN CETYL ALCOHOL POLYGLYCERYL-10 DECAOLEATE SUNFLOWER OIL STEVIOSIDE BENZALDEHYDE DIMETHYLHYDROXY FURANONE 2-HEXENAL, (2E)- TOCOPHEROL SOYBEAN OIL TRIHYDROXYSTEARIN POLYISOBUTYLENE (1300 MW) DIETHYLHEXYL 2,6-NAPHTHALATE HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE
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.Supergoop! PLAY SPF 30 LIP BALM with Acai Broad Spectrum Sunscreen SPF 30 0.5 fl. oz./ 15 ml. Carton
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. 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 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