Label: COLA DEW GOOD ILLUMINATING BODY MELT SPF 40- avobenzone, octisalate, octocrylene cream
- NDC Code(s): 79753-082-01
- Packager: COOLA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 22, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
Directions
• Apply liberally 15 minutes before sun exposure
• Reapply: • After 40 minutes of swimming or sweating.
• Immediately after towel drying. • Apply 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. to 2 p.m. • Wear long-sleeved shirts, pants,
hats, and sunglasses. • Children under 6 months: Ask a doctor. - OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Carthamus Tinctorius (Safflower),
Oleosomes (ORGANIC), Water, Caprylic/Capric Triglyceride (ORGANIC), Cocos
Nucifera (Coconut) Oil (ORGANIC), Ethylhexyl Methoxycrylene, Methyl
Dihydroabietate, Mica, Glycerin (ORGANIC), Glyceryl Stearate,
Stearyl/Octyldodecyl Citrate Crosspolymer, Polyacrylate Crosspolymer-6,
Butyrospermum Parkii (Shea) Butter (ORGANIC), Lactobacillus Ferment, Sodium
Hyaluronate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethyl Ferulate,
Caprylyl Glycol, 1,2-Hexanediol, Titanium Dioxide, Stearic Acid, Sodium Stearoyl
Glutamate, Dimethicone, Sodium Phytate, Xanthan Gum, Maltodextrin, Sodium
Hydroxide, Polysilicone-11, Butylene Glycol, Tropolone,
Decyl Glucoside, Fragrance (Natural) - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLA DEW GOOD ILLUMINATING BODY MELT SPF 40
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-082 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 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8.0 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SAFFLOWER (UNII: 4VBL71TY4Y) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) MICA (UNII: V8A1AW0880) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) SHEA BUTTER (UNII: K49155WL9Y) LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) HYALURONATE SODIUM (UNII: YSE9PPT4TH) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ETHYL FERULATE (UNII: 5B8915UELW) CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) PHYTATE SODIUM (UNII: 88496G1ERL) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM HYDROXIDE (UNII: 55X04QC32I) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TROPOLONE (UNII: 7L6DL16P1T) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-082-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 06/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/24/2024 Labeler - COOLA LLC (956990290)