Label: EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate cream
- NDC Code(s): 75936-210-01, 75936-210-03
- 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 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply gerenously and evenly 15 minutes before sun exsposure
- Reapply
after 80 minutes of swimming or sweating
immediately after towel drying
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 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
-
INACTIVE INGREDIENT
Inactive Ingredients
Water, Polyester-8, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Campstris/Aleurites Fordi Oil Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Roseodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethyhexylglycerin, Eucaluptyus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamine Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EVERYDAY SUNSCREEN WITH SUNFLOWER EXTRACT BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-210 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ROSEWOOD OIL (UNII: F2522O5L7B) CHLORPHENESIN (UNII: I670DAL4SZ) ORANGE OIL (UNII: AKN3KSD11B) LEMON OIL (UNII: I9GRO824LL) GLYCERIN (UNII: PDC6A3C0OX) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) WATER (UNII: 059QF0KO0R) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) ISODODECANE (UNII: A8289P68Y2) LAURYL LACTATE (UNII: G5SU0BFK7O) CETYL ALCOHOL (UNII: 936JST6JCN) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) RICE BRAN (UNII: R60QEP13IC) CETEARYL OLIVATE (UNII: 58B69Q84JO) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SORBITAN OLIVATE (UNII: MDL271E3GR) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) PENTYLENE GLYCOL (UNII: 50C1307PZG) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) BEHENIC ACID (UNII: H390488X0A) CETYL BEHENATE (UNII: WFM51TRO3E) ISOSTEARYL STEARATE (UNII: E08UTG6X4W) TOCOPHEROL (UNII: R0ZB2556P8) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-210-01 71 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2019 2 NDC:75936-210-03 162 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/12/2019 Labeler - Supergoop, LLC (117061743)
