Label: SUPERSCREEN HYDRATING DAILY CREAM SPF 40- avobenzone, homosalate, octisalate, octocrylene cream
- NDC Code(s): 75936-620-01, 75936-620-02
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
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 June 26, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
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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 time in the sun, especially from 10 a.m.- 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUPERSCREEN HYDRATING DAILY CREAM SPF 40
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-620 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ECTOINE (UNII: 7GXZ3858RY) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL TRIOLEATE (UNII: O05EC62663) INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG) WATER (UNII: 059QF0KO0R) POLYESTER-7 (UNII: 0841698D2F) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CHLORPHENESIN (UNII: I670DAL4SZ) APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X) GLYCERYL DIOLEATE (UNII: Z3MP1W91CW) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) CERAMIDE NP (UNII: 4370DF050B) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-620-02 1 in 1 BOX 06/26/2023 1 NDC:75936-620-01 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/26/2023 Labeler - Supergoop, LLC (117061743)