Label: HAND SCREEN BROAD SPECTRUM SUNSCREEN SPF 40- avobenzone, octisalate, octocrylene lotion
- NDC Code(s): 75936-151-01, 75936-151-02, 75936-151-03
- 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 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
Water, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Propanediol, Glyceryl Stearate Citrate, Cocoglycerides, Isododecane, Cetyl Esters, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Arginine, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Polymethylsilsequioxane, Raphanus Sativus (Radish) Seed Oil, Diethylhexyl syringylidenemalonate, Helianthuus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Argania Spinosa Kernel Oil, Caprylic/Capric Triglyceride, Citrus Nobilis (Madarin Orange) Peel Oil, Plantago Lanceolata Leaf Extract, Glycine Soja (Soybean) Oil, Tocopherol, Cymbopogon Schoenanthus Oil, Hippophae Rhamnoides Fruit Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia Leaf Oil, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Grosso Herb Oil
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAND SCREEN BROAD SPECTRUM SUNSCREEN SPF 40
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 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 Inactive Ingredients Ingredient Name Strength MANDARIN OIL (UNII: NJO720F72R) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) CHLORPHENESIN (UNII: I670DAL4SZ) CETYL ESTERS WAX (UNII: D072FFP9GU) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISODODECANE (UNII: A8289P68Y2) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) CARDAMOM OIL (UNII: JM0KJ091HZ) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) EUCALYPTUS OIL (UNII: 2R04ONI662) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ARGAN OIL (UNII: 4V59G5UW9X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CLOVE LEAF OIL (UNII: VCA5491KVF) PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8) LAURYL LACTATE (UNII: G5SU0BFK7O) ARGININE (UNII: 94ZLA3W45F) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) PROPANEDIOL (UNII: 5965N8W85T) CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y) VANILLIN (UNII: CHI530446X) COCO-GLYCERIDES (UNII: ISE9I7DNUG) CETYL PHOSPHATE (UNII: VT07D6X67O) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-151-01 4 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/12/2019 2 NDC:75936-151-02 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/12/2019 3 NDC:75936-151-03 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/12/2019 Labeler - Supergoop, LLC (117061743)
