Label: MILD CARE SUNCREAM- zinc oxide cream
- NDC Code(s): 76344-8006-2
- 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
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- Official Label (Printer Friendly)
- Drug Facts 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,PROPYLHEPTYL CAPRYLATE,LAURYL POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE,ISODODECANE,ISOTRIDECYL ISONONANOATE,POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE,DISTEARDIMONIUM HECTORITE,MAGNESIUM SULFATE,TRIETHOXYCAPRYLYLSILANE,GLYCOL DIMETHACRYLATE,1,2-HEXANEDIOL,POLYHYDROXYSTEARIC ACID,GLYCERYL CAPRYLATE,CAPRYLYL GLYCOL,POLYMETHYLSILSESQUIOXANE,PANTHENOL,ETHYLHEXYLGLYCERIN,TOCOPHEROL,CERAMIDE NP,SUCROSE STEARATE,CHOLESTEROL,STEARIC ACID,CHOLESTERYL MACADAMIATE,PALMITIC ACID,SACCHARIDE ISOMERATE
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INGREDIENTS AND APPEARANCE
MILD CARE SUNCREAM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76344-8006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15.44 g in 100 mL Inactive Ingredients Ingredient Name Strength ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) 2 g in 100 mL MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 0.8 g in 100 mL TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.63 g in 100 mL POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) 0.1 g in 100 mL PANTHENOL (UNII: WV9CM0O67Z) 0.07 g in 100 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.04 g in 100 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.01 g in 100 mL CHOLESTERYL MACADAMIATE (UNII: DFP79OD7KP) 0.01 g in 100 mL PALMITIC ACID (UNII: 2V16EO95H1) 0.01 g in 100 mL SACCHARIDE ISOMERATE (UNII: W8K377W98I) 0.01 g in 100 mL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) 2.39 g in 100 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.1 g in 100 mL SUCROSE STEARATE (UNII: 274KW0O50M) 0.01 h in 100 mL CHOLESTEROL (UNII: 97C5T2UQ7J) 0.01 g in 100 mL STEARIC ACID (UNII: 4ELV7Z65AP) 0.01 g in 100 mL PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD) 12.49 g in 100 mL ISODODECANE (UNII: A8289P68Y2) 2 g in 100 mL DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) 0.8 g in 100 mL GLYCOL DIMETHACRYLATE (UNII: 7BK5G69305) 0.6 g in 100 mL 1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.3 g in 100 mL POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.16 g in 100 mL GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 0.1 g in 100 mL CERAMIDE NP (UNII: 4370DF050B) 0.01 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76344-8006-2 1 in 1 BOX 01/01/2021 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 01/01/2021 Labeler - HUMEX,INC. (017945311) Establishment Name Address ID/FEI Business Operations Kolmar Korea 689512611 manufacture(76344-8006)
