Label: GLOW OIL BROAD SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 75936-152-01, 75936-152-02
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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.
- after 80 minutes 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
Caprylic/Capric Triglyceride, Alcohol, Octyldodecanol, C12-15 Alkyl Benzoate, Polyester-8, Polyamide-3, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Diethylhexylsyringylidenemalonate, Tocopherol, Glycine Soja (Soybean)Oil, Vitis Vinifera (grape) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Limnanthes Alba(Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (coconut) Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Pentaerythrityl Tetra-di-t-butyl hydroxyhydrocinnamate. Alaria Esculanta Extract, t-Butyl Alcohol, Cucumis Sativus(cucumber) Fruit Extract, Denatonium Benzoate, Citric Acid
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GLOW OIL BROAD SPECTRUM SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-152 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 10 g in 100 mL Inactive Ingredients Ingredient Name Strength DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CUCUMBER (UNII: YY7C30VXJT) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SUNFLOWER OIL (UNII: 3W1JG795YI) ARGAN OIL (UNII: 4V59G5UW9X) ALARIA ESCULENTA (UNII: EJ9JK8J58D) SHEA BUTTER (UNII: K49155WL9Y) GRAPE SEED OIL (UNII: 930MLC8XGG) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) OCTYLDODECANOL (UNII: 461N1O614Y) LAURYL LACTATE (UNII: G5SU0BFK7O) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X) COCONUT OIL (UNII: Q9L0O73W7L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALCOHOL (UNII: 3K9958V90M) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-152-01 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/12/2019 2 NDC:75936-152-02 30 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)