Label: CARECELLA DAY CREAM- avobenzone, octinoxate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69422-1302-1 - Packager: General Bio Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 29, 2017
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
• Apply liberally and evenly 15 minutes before sun exposure
• Children under 6 months of age: Ask a doctor
• Reapply at least every 2 hours
• Use a water resistant sunscreen 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 time in the sun, especially from 10 a.m.- 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
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Inactive ingredients
Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, C12-15 Alkyl Benzoate, Niacinamide, Butylene Glycol, Dipropylene Glycol, Trisiloxane, Common Purslane (Portulaca Oleracea) Extract, 1,2-Hexanediol, Magnesium Aluminum Silicate, Arginine, Cetearyl Olivate, Sorbitan Olivate, Glyceryl Stearate, Cetearyl Alcohol, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Glycerin, Disodium EDTA, Scots Pine (Pinus sylvestris) Leaf Oil, Adenosine, Sodium Hyaluronate, Hydrolyzed Collagen Extract, Comfrey (Symphytum Officinale) Leaf Extract, Hydrogenated Lecithin, Diethoxyethyl Succinate, Phospholipids, Caprylic/Capric Triglyceride, Ceramide NP, Wild Mint (Mentha Arvensis) Leaf Oil, Polyglyceryl-10 Laurate, Caprylyl Glycol, Copper Tripeptide-1, Tripeptide-29, Nicotinoyl Tripeptide-1, Hexapeptide-9, Acetyl Hexapeptide-8
- Other information
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- Packaging
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INGREDIENTS AND APPEARANCE
CARECELLA DAY CREAM
avobenzone, octinoxate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69422-1302 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NIACINAMIDE (UNII: 25X51I8RD4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIPROPYLENE GLYCOL (UNII: E107L85C40) TRISILOXANE (UNII: 9G1ZW13R0G) PURSLANE (UNII: M6S840WXG5) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ARGININE (UNII: 94ZLA3W45F) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLORPHENESIN (UNII: I670DAL4SZ) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) ADENOSINE (UNII: K72T3FS567) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) COMFREY LEAF (UNII: DG4F8T839X) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) DIETHOXYETHYL SUCCINATE (UNII: R1B8ZV94R9) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CERAMIDE NP (UNII: 4370DF050B) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PREZATIDE COPPER (UNII: 6BJQ43T1I9) ACV TRIPEPTIDE (UNII: O3VOU3H9VS) NICOTINURIC ACID (UNII: 77V5315PIU) HEXAPEPTIDE-10 (UNII: W9RS1K7T9I) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69422-1302-1 1 in 1 BOX 12/19/2017 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/19/2017 Labeler - General Bio Co., Ltd. (688299527)
