Label: FARMHOUSE FRESH ELEVATED SHADE SPF 30- zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 72788-101-12 - Packager: SUMMER SOLES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
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:- Limit time in the sun, especially from 10a.m. - 2p.m.
- wear long sleeve shirts, pants, hats and sunglasses.
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating - Other Information
-
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.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FARMHOUSE FRESH ELEVATED SHADE SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72788-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 21 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72788-101-12 1 in 1 CARTON 04/04/2020 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/04/2020 Labeler - SUMMER SOLES LLC (780418674)
