SKINFOOD ALOE WATERY SUN WATERPROOF by SKINFOOD CO.,LTD. / IPEERES COSMETICS CO., LTD.

SKINFOOD ALOE WATERY SUN WATERPROOF by

Drug Labeling and Warnings

SKINFOOD ALOE WATERY SUN WATERPROOF by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO.,LTD., IPEERES COSMETICS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKINFOOD ALOE WATERY SUN WATERPROOF- zinc oxide, octinoxate, octisalate, titanium dioxide cream 
SKINFOOD CO.,LTD.

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.

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ACTIVE INGREDIENT

Active Ingredients: ZINC OXIDE 12.8%, OCTYL METHOXYCINNAMATE 7.00%, OCTYL SALICYLATE 4.50%, TITANIUM DIOXIDE 1.66%

INACTIVE INGREDIENT

Inactive Ingredients: CYCLOPENTASILOXANE, WATER, ALOE BARBADENSIS LEAF EXTRACT, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, STEARALKONIUM HECTORITE, METHYL METHACRYLATE CROSSPOLYMER, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, PROPYLENE CARBONATE, SODIUM CHLORIDE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, FRAGRANCE, CHAMOMILLA RECUTITA (MATRICARIA) EXTRACT, HIZIKIA FUSIFORME EXTRACT, TOCOPHEROL

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 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 product is swallowed, get medicalhelp or contact a Poison Control Center right away.

DESCRIPTION

Use: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions: Apply liberally 15 minutes before sun exposure. 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. Children under 6 months of age: Ask a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

SKINFOOD ALOE WATERY SUN WATERPROOF 
zinc oxide, octinoxate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76214-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.4 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.2 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.8 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76214-065-0150 mL in 1 TUBE; Type 0: Not a Combination Product08/01/201611/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201611/01/2019
Labeler - SKINFOOD CO.,LTD. (690324173)
Registrant - SKINFOOD CO.,LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
IPEERES COSMETICS CO., LTD.687590526manufacture(76214-065)

Revised: 12/2019
 
SKINFOOD CO.,LTD.