ELEVATED ULTIMATE SUN DEFENSE BROADSPECTRUM SPF 30 (UVA/UVB) SUNSCREEN- titanium dioxide and zinc oxide liquid 
Elevated Dermatology and Skin

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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Elevated Ultimate Sun Defense Broad Spectrum SPF30 (UVA/UVB) Sunscreen

DRUG FACTS:

ACTIVE INGREDIENTS

Titanium Dioxide 7.2%, Zinc Oxide 4.0%.

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.

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), Butyloctyl Salicylate, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Propanediol, Polyglyceryl-10 Oleate, Coco-Caprylate/Caprate, Styrene/Acrylates Copolymer, Polyhydroxystearic Acid, Rosa Damascena Flower Water, Phenoxyethanol, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Alumina, Butylene Glycol, Polyglyceryl-2 Caprate, Microcrystalline Cellulose, Potassium Cetyl Phosphate, Polyglyceryl-3 Polyricinoleate, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Marrubium Vulgare Meristem Cell Culture, Polyglyceryl-3 Diisostearate, Triethoxycaprylylsilane, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Cellulose Gum, Glyceryl Caprylate, Squalane, Carbomer, Polysorbate 20, Aspalathus Linearis Extract, Palmitoyl Tripeptide-1, Xanthan Gum, Palmitoyl Tetrapeptide-7, Polygonum Aviculare Extract.

OTHER INFORMATION

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

Elevated Ultimate
Sun Defense
BroadSpectrum SPF 30
(UVA/UVB) Sunscreen
1.75 fl oz (50 ml)

Elevated Ultimate Sun Defense BroadSpectrum SPF 30 (UVA/UVB) SunscreenElevated Ultimate
Sun Defense
BroadSpectrum SPF 30
(UVA/UVB) Sunscreen

ELEVATED ULTIMATE SUN DEFENSE BROADSPECTRUM SPF 30 (UVA/UVB) SUNSCREEN 
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81688-2750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPANEDIOL (UNII: 5965N8W85T)  
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
JOJOBA OIL (UNII: 724GKU717M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
SQUALANE (UNII: GW89575KF9)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81688-2750-350 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 - Elevated Dermatology and Skin (094623214)

Revised: 4/2021
Document Id: c095bcfc-f9e7-a6e9-e053-2995a90ae9f2
Set id: c095bcfc-f9eb-a6e9-e053-2995a90ae9f2
Version: 1
Effective Time: 20210422
 
Elevated Dermatology and Skin