Label: RECIPE INFINITE UV SHIELD SUNSCREEN BROAD SPECTRUM SPF100- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 80670-001-00 - Packager: BAY BELLE LABS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 November 29, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Bottle
-
DOSAGE & ADMINISTRATION
- Apply generously 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- 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: limit time in the sun, especially from 10 a.m.-2p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
- Children under 6 months of age: ask a doctor.
- WARNINGS
-
INACTIVE INGREDIENT
Water, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dipropylene Glycol, Alcohol Denat., Caprylyl Methicone, Cetyl Alcohol, PPG-8-Ceteth-20, Polysorbate 60, Dimethicone, Hydroxyacetophenone, Phenoxyethanol, Hydrolyzed Wheat Protein/PVP Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance(Parfum), Isohexadecane, Tocopheryl Acetate, Potassium Hydroxide, Polysorbate 80, Disodium EDTA, Butylene Glycol, Sorbitan Oleate, Lilium Candidum Flower Water, Hydrolyzed Pearl, Glycerin, Xylitylglucoside, Potassium Sorbate, Beta Vulgaris (Beet) Root Extract, Anhydroxylitol, Ethylhexylglycerin, Haberlea Rhodopensis Leaf Extract, Xylitol, Glutathione, Resveratrol, Ascorbyl Glucoside, Saussurea Involucrata Extract, Glucose, Oryza Sativa (Rice) Extract, Hydrolyzed Myrtus Communis Leaf Extract, Yeast Extract, Sesamum Indicum (Sesame) Seed Extract, Glycine Soja (Soybean) Seed Extract, Leontopodium Alpinum Flower/Leaf Extract, Myrciaria Dubia Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Epigallocatechin Gallatyl Glucoside, Euterpe Oleracea Fruit Extract, Caprylyl Glycol, Caprylhydroxamic Acid, Epigallocatechin Gallate
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ACTIVE INGREDIENT
- Carton
-
INGREDIENTS AND APPEARANCE
RECIPE INFINITE UV SHIELD SUNSCREEN BROAD SPECTRUM SPF100
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80670-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength BLACKBERRY MESOCARP FREEZE DRIED (UNII: RN3FTI5O77) 0.001 mg in 1 mL YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) 0.003 mg in 1 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.0002 mg in 1 mL RICE GERM (UNII: 7N2B70SFEZ) 0.004 mg in 1 mL SESAME SEED (UNII: 7Y1255HVXR) 0.003 mg in 1 mL CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) 30 mg in 1 mL BEET (UNII: N487KM8COK) 0.036 mg in 1 mL LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.018 mg in 1 mL SOYBEAN (UNII: L7HT8F1ZOD) 0.002 mg in 1 mL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) 3 mg in 1 mL EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.31 mg in 1 mL BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.216 mg in 1 mL XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) 0.04 mg in 1 mL ANHYDROXYLITOL (UNII: 8XWR7NN42F) 0.028 mg in 1 mL SAUSSUREA INVOLUCRATA WHOLE (UNII: C7X2ALW7JZ) 0.005 mg in 1 mL ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 0.004 mg in 1 mL XYLITOL (UNII: VCQ006KQ1E) 0.012 mg in 1 mL MYRTUS COMMUNIS LEAF (UNII: U20N87188F) 0.0035 mg in 1 mL CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.0001 mg in 1 mL EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) 0.000025 mg in 1 mL POLYSORBATE 60 (UNII: CAL22UVI4M) 10 mg in 1 mL BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 80 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0202 mg in 1 mL ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) 0.01 mg in 1 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 50 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) 30 mg in 1 mL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) 3.5 mg in 1 mL WATER (UNII: 059QF0KO0R) 435.65785 mg in 1 mL HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) 5 mg in 1 mL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 2 mg in 1 mL ISOHEXADECANE (UNII: 918X1OUF1E) 1.8 mg in 1 mL POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) 1 mg in 1 mL DIMETHICONE (UNII: 92RU3N3Y1O) 5 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 4.1815 mg in 1 mL CALCIUM CARBONATE (UNII: H0G9379FGK) 0.0975 mg in 1 mL GLUTATHIONE (UNII: GAN16C9B8O) 0.01 mg in 1 mL RESVERATROL (UNII: Q369O8926L) 0.01 mg in 1 mL HABERLEA RHODOPENSIS LEAF (UNII: N042Q65701) 0.0125 mg in 1 mL CETYL ALCOHOL (UNII: 936JST6JCN) 12 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) 0.0901 mg in 1 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.04 mg in 1 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1 mg in 1 mL POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.6 mg in 1 mL SORBITAN MONOOLEATE (UNII: 06XEA2VD56) 0.2 mg in 1 mL LILIUM CANDIDUM FLOWER OIL (UNII: 6RQW4206B6) 0.0995 mg in 1 mL MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP) 0.001 mg in 1 mL LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) 0.001 mg in 1 mL ACAI (UNII: 46AM2VJ0AW) 0.0005 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80670-001-00 1 in 1 CARTON 09/17/2020 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/17/2020 Labeler - BAY BELLE LABS (034915412) Registrant - COSMAX USA, INC. (COSMAX USA, CORPORATION) (010990210) Establishment Name Address ID/FEI Business Operations COSMAX USA, INC. (COSMAX USA, CORPORATION) 010990210 manufacture(80670-001)
