Label: DEW GOOD ILLUMINATING SERUM- avobenzone 3%, homosalate 4%, octocrylene 8% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 79753-034-01 - Packager: COOLA
- 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 December 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• Shake well • apply liberally 15 minutes before sun exposure
• reapply:• after 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 of 15 or higher and after sun protection.
measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Butolyctyl Salicylate,
Glycerin, Ammonium Acryloldimethyltaurate/VP
Copolymer, Bismuth Oxychloride, Lactobacillus
Ferment, Jasmine Sambach (Jasmine) Leaf Cell
Extract, Theodora Cacao (Cocoa) Seed Extract,
Schinus Molle Extract, Water, Titanium Dioxide, Ethyl
Ferulate, Tropolone, Mica, Hydroxyacetophenone,
Propanediol, Butylene Glycol, Sodium Stearoyl,
Glutamats, 1,2-Hexanediol, Caprylyl Glycol,
Ethylhexyl Hydroxystearate, Maltodextrin, Sodium
Phylate, Fragrance (Natural) - OTHER SAFETY INFORMATION
- QUESTIONS
- COOLA Dew Good Package Label
-
INGREDIENTS AND APPEARANCE
DEW GOOD ILLUMINATING SERUM
avobenzone 3%, homosalate 4%, octocrylene 8% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.0 mg in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8.0 mg in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) JASMINUM SAMBAC FLOWER (UNII: 2S686I937F) COCOA (UNII: D9108TZ9KG) SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ETHYL FERULATE (UNII: 5B8915UELW) TROPOLONE (UNII: 7L6DL16P1T) MICA (UNII: V8A1AW0880) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) MALTODEXTRIN (UNII: 7CVR7L4A2D) PHYTATE SODIUM (UNII: 88496G1ERL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-034-01 1 in 1 CARTON 02/01/2022 1 35 mL in 1 BOTTLE; 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 02/01/2022 Labeler - COOLA (956990290)
