RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 by BAY BELLE LABS / COSMAX USA, INC. (COSMAX USA, CORPORATION)

RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 by

Drug Labeling and Warnings

RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 by is a Otc medication manufactured, distributed, or labeled by BAY BELLE LABS, COSMAX USA, INC. (COSMAX USA, CORPORATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RECIPE INFINITE UV SHIELD SUNSCREEN BROAD SPECTRUM SPF100- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion 
BAY BELLE LABS

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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Bottle

• 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.

For external use only.

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

If swallowed get medical help or contact a Poison Control Center right away.

Sunscreen

Avobenzone 3%, Homosalate 9%, Octinoxate 5%, Octisalate 4%, Octocrylene 3%, Purpose: Sunscreen

Carton

RECIPE INFINITE UV SHIELD SUNSCREEN BROAD SPECTRUM SPF100 
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion

Product 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)

Revised: 11/2021

Document Id: d1f06b5a-744e-cbde-e053-2a95a90a5ea9

34390-5

Set id: b0254b0c-325f-96d9-e053-2a95a90ad8b4

Version: 4

Effective Time: 20211129