Label: LIP SCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octisalate, octocrylene liquid
- NDC Code(s): 75936-257-01
- 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
Use a water-resistant sunscreen if swimming or sweating
Reapply at least every 2 hours.
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, Diisostearyl Malate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Polyurethane-79, Polyester-7, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Isopropyl Palmitate , Sesamum Inidicum (Sesame) Seed Oil, Neopentyl Glycol Diheptanoate, Diethylhexyl Syringlidenemalonate, Caprylyl Glycol, Glycine Soja (Soybean) Oil, Tocopherol, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Helianthus Annuus (Sunflower) Seed Oil, Ethyl Acetate, Stevioside, Gamma-Undecalactone, Vanillin, Vitis Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract, Citric Acid
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIP SCREEN BROAD SPECTRUM SPF 40
avobenzone, homosalate, octisalate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-257 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYL ACETATE (UNII: 76845O8NMZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYESTER-7 (UNII: 0841698D2F) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A) 2-HEXENAL, (2E)- (UNII: 69JX3AIR1I) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) LAMINARIA OCHROLEUCA (UNII: 4R2124HE76) AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V) VANILLIN (UNII: CHI530446X) 2-METHYLBUTYRIC ACID (UNII: PX7ZNN5GXK) SESAME OIL (UNII: QX10HYY4QV) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) STEVIOSIDE (UNII: 0YON5MXJ9P) VITIS VINIFERA SEED (UNII: C34U15ICXA) SHEA BUTTER (UNII: K49155WL9Y) COCONUT OIL (UNII: Q9L0O73W7L) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SOYBEAN OIL (UNII: 241ATL177A) BENZALDEHYDE (UNII: TA269SD04T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-257-01 10 mL in 1 TUBE; Type 0: Not a Combination Product 04/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/22/2020 Labeler - Supergoop, LLC (117061743)