Label: REJUVE SUNSCREEN 100- inc oxide,octinoxate,octisalate,homosalate,titanium dioxide cream
- NDC Code(s): 76344-8005-1, 76344-8005-2
- Packager: HUMEX,INC.
- 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 January 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
- Uses
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Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. - Directions
- Other Information
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Inactive Ingredients
Water, Cyclomethicone,Glycerin,Propanediol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite,Magnesium Sulfate,Dimethicone,Glycol Dimethacrylate,Methyl Methacrylate Crosspolymer,Vinyl Dimethicone/Methicone,Silsesquioxane Crosspolymer,Triethoxycaprylylsilane,Fragrance,
Dimethicone/Peg-10/15 Crosspolymer,
Dimethicone/Vinyl Dimethicone,Crosspolymer,
Glyceryl Caprylate,Ethylhexylglycerin,Dipropylene Glycol,Ceramide Np,Sucrose Stearate,Sodium Citrate,Tocopherol,Cholesterol,Stearic Acid,Cholesteryl Macadamiate,Palmitic Acid,Butylene Glycol,Saccharide Isomerate,
Dipeptide Diaminobutyroyl Benzylamide,
Diacetate,Palmitoyl Tripeptide-5,Oligopeptide-10 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REJUVE SUNSCREEN 100
inc oxide,octinoxate,octisalate,homosalate,titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76344-8005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 0.12 mL in 100 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.01 mL in 100 mL SACCHARIDE ISOMERATE (UNII: W8K377W98I) 0.01 mL in 100 mL OLIGOPEPTIDE-10 (UNII: Q46328TRNK) 0.01 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 3 mL in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 3 mL in 100 mL SUCROSE STEARATE (UNII: 274KW0O50M) 0.01 mL in 100 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.01 mL in 100 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.01 mL in 100 mL STEARIC ACID (UNII: 4ELV7Z65AP) 0.01 mL in 100 mL PALMITIC ACID (UNII: 2V16EO95H1) 0.01 mL in 100 mL GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 0.1 mL in 100 mL LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) 2.49 mL in 100 mL DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.8 mL in 100 mL MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 0.8 mL in 100 mL DIMETHICONE (UNII: 92RU3N3Y1O) 0.52 mL in 100 mL GLYCOL DIMETHACRYLATE (UNII: 7BK5G69305) 0.5 mL in 100 mL 1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.5 mL in 100 mL VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) 0.5 mL in 100 mL TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.46 mL in 100 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.04 mL in 100 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.01 mL in 100 mL CERAMIDE NP (UNII: 4370DF050B) 0.01 mL in 100 mL PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) 0.01 mL in 100 mL CHOLESTEROL (UNII: 97C5T2UQ7J) 0.01 mL in 100 mL CHOLESTERYL MACADAMIATE (UNII: DFP79OD7KP) 0.01 mL in 100 mL DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R) 0.01 mL in 100 mL CYCLOMETHICONE (UNII: NMQ347994Z) 19.08 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76344-8005-2 1 in 1 BOX 12/01/2020 1 NDC:76344-8005-1 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 final part352 12/01/2020 Labeler - HUMEX,INC. (017945311) Establishment Name Address ID/FEI Business Operations Kolmar Korea 689512611 manufacture(76344-8005)
