Label: PLAY LIP BALM WITH ACAI BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene stick
- NDC Code(s): 75936-225-01
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 11, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PLAY LIP BALM WITH ACAI BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-225 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYL ACETATE (UNII: 76845O8NMZ) SHEANUT (UNII: 84H6HBP32L) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SAFFLOWER OIL (UNII: 65UEH262IS) SESAME OIL (UNII: QX10HYY4QV) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) 2-METHYLBUTYRIC ACID (UNII: PX7ZNN5GXK) ACAI (UNII: 46AM2VJ0AW) AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V) VANILLIN (UNII: CHI530446X) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) CERESIN (UNII: Q1LS2UJO3A) CETYL ALCOHOL (UNII: 936JST6JCN) POLYGLYCERYL-10 DECAOLEATE (UNII: NJR3XZA3NW) SUNFLOWER OIL (UNII: 3W1JG795YI) STEVIOSIDE (UNII: 0YON5MXJ9P) BENZALDEHYDE (UNII: TA269SD04T) DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A) 2-HEXENAL, (2E)- (UNII: 69JX3AIR1I) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-225-01 15 mL in 1 CARTON; Type 0: Not a Combination Product 02/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/27/2020 Labeler - Supergoop, LLC (117061743)
