Otc - Active Ingredient
Active Ingredients Purpose
Avobenozone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Play Lip Balm With Acai Broad Spectrum Spf 30 Stick
FDA Label NDC 75936-225
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Supergoop, Llc for the product Play Lip Balm With Acai Broad Spectrum Spf 30 (NDC 75936-225). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If product is swallowed, get medical help or contact a poison Control Center right away
Indications & Usage
Stop use and ask a doctor if rash occurs.
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
Dosage & Administration
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
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
Package Label.Principal Display Panel
Supergoop!
PLAY
SPF 30
LIP BALM with Acai
Broad Spectrum Sunscreen SPF 30
0.5 fl. oz./ 15 ml.
* Please review the disclaimer below.
