FARMHOUSE FRESH ELEVATED SHADE SPF 30- zinc oxide cream 
SUMMER SOLES 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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FARMHOUSE FRESH ELEVATED SHADE SPF 30

ACTIVE INGREDIENTS

Zinc Oxide 21.50%

PURPOSE

SUNSCREEN

Uses

Warnings

Keep out of reach of children If swallowed, get medicl help or contact poison control center.

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: ask doctor.
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:

Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating

Other Information

Protect the product in this contianer from heat and direct sun.

INACTIVE INGREDIENTS

Water/Eau, Caprylic/Capric Triglyceride, Ethyl Macadamiate, Glycerin, Propanediol, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Polyglyceryl-10 Stearate, Cetearyl Olivate, Xanthan Gum, Magnesium Aluminum Silicate, Sodium Hyaluronate, Sodium PCA, Niacinamide, Allantoin, Quercetin, Sodium Ascorbyl Phosphate, Camellia Sinensis Leaf Extract, Sodium Chloride, Glyceryl Isostearate, Polyhydroxystearic, Sorbital Olivate, Linum Usitatissmum (flax) seed oil, Tocopherol, Iron Oxides, Triethoxysilylpropyl Acetyl Hydroxyprolinate, Phenoxyethanol, Caprylyl Glycol, Polymethyl Methacrylate, Tromethamine, Pisum sativum (Dwarf Gray Sugar Pea) Extract, Parfum* *Natural fragrance derived from 100% natural sources.

image description

FARMHOUSE FRESH ELEVATED SHADE  SPF 30
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72788-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ALLANTOIN (UNII: 344S277G0Z)  
QUERCETIN (UNII: 9IKM0I5T1E)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
FLAX SEED (UNII: 4110YT348C)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYSILYLPROPYL STEARDIMONIUM (UNII: 2606S334CS)  
OXACEPROL (UNII: Q0XV76B96L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
TROMETHAMINE (UNII: 023C2WHX2V)  
PISUM SATIVUM WHOLE (UNII: J21YE3W98E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72788-101-121 in 1 CARTON04/04/2020
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/04/2020
Labeler - SUMMER SOLES LLC (780418674)

Revised: 12/2020
Document Id: b10c9d19-cd6b-445d-9683-9bfad0b498a5
Set id: 01faba9d-5229-4737-9cd5-3e7048b8eb5b
Version: 1
Effective Time: 20201228
 
SUMMER SOLES LLC