ANTIOXIDANT TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF30- titanium dioxide and zinc oxide cream 
Skinhealth Studios LLC

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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Antioxidant MineralSunscreen Broad Spectrum SPF30

DRUG FACTS:

ACTIVE INGREDIENTS

Titanium Dioxide 7.75%, Zinc Oxide 10.0%.

Purpose

Sunscreen

USES

Helps prevent sunburn.

WARNINGS

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.

DIRECTIONS

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor. 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:

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Polygonum Aviculare Extract, Tocopheryl Acetate, Perilla Frutescens Extract, Vitis Vinifera Fruit Cell Extract, Lepidium Sativum Sprout Extract, Squalane, Cetearyl Alcohol, Isononyl Isononanoate, Coco-Glucoside, Pentylene Glycol, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Phenethyl Alcohol, Tetrahexyldecyl Ascorbate, Glyceryl Caprylate, Ethylene/Propylene/Styrene Copolymer, Sorbitan Oleate, Polyglyceryl-2 Caprate, Propanediol, Alumina, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491, CI 77499).

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

Antioxidant Mineral Sunscreen
Broad Spectrum SPF30

Antioxidant Mineral Sunscreen
Broad Spectrum SPF30 Antioxidant Mineral Sunscreen Broad Spectrum SPF30

ANTIOXIDANT TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF30 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83200-0650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.75 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
SQUALANE (UNII: GW89575KF9)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
COCO GLUCOSIDE (UNII: ICS790225B)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DOCOSANOL (UNII: 9G1OE216XY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
JOJOBA OIL (UNII: 724GKU717M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83200-0650-250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2023
Labeler - Skinhealth Studios LLC (046550958)

Revised: 1/2023
Document Id: f31d5e85-7364-3523-e053-2995a90a7897
Set id: f31d5599-0e04-19f0-e053-2a95a90a3c5c
Version: 1
Effective Time: 20230125
 
Skinhealth Studios LLC