BROAD SPECTRUM SPF 30 TINTED MINERAL DEFENSE SUNSCREEN- titanium dioxide and zinc oxide cream 
Advanced Body and Laser Center

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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Broad Spectrum SPF 30 Tinted Mineral Defense Sunscreen

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.

Advanced Body and Laser Center
Broad Spectrum SPF 30
Tinted Mineral Defense Sunscreen
1.75 fl oz (50ml)

Advanced Body and Laser Center Broad Spectrum SPF 30 Tinted Mineral Defense Sunscreen 1.75 fl oz (50ml)Advanced Body and Laser Center
Broad Spectrum SPF 30
Tinted Mineral Defense Sunscreen
1.75 fl oz (50ml)

BROAD SPECTRUM SPF 30 TINTED MINERAL DEFENSE SUNSCREEN 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81728-0650
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:81728-0650-350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2021
Labeler - Advanced Body and Laser Center (025487743)

Revised: 4/2021
Document Id: bfdf37f2-2af9-6874-e053-2a95a90a26fa
Set id: bfdf40d7-3ea9-41e0-e053-2995a90ace38
Version: 1
Effective Time: 20210413
 
Advanced Body and Laser Center