Spa Pharma Anti-Aging Acocado Cream SPF 25 Listing

Drug Labeling and Warnings

Drug Details [pdf]

SPA PHARMA ANTI-AGING ACOCADO CREAM SPF 25 LISTING- octinoxate,octocrylene, octisalate, avobenzone, homosalate cream cream 
Peer Pharm Ltd.

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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Spa Pharma Anti-Aging Acocado Cream SPF 25 Listing

Octinoxate 7.5%

Octocrylene 5%

Octisalate 5%
Avobenzone 3%

Homosalate 2%

Keep out of reach of children

Provides SPF 25 sun protection

Smooths wrnkles, helps prevent the apperance of new wrinkles, encourages the production of elastin and collagen and so improves the elasticity of the kin, firms, refines, and restores moisture concentration. Helps prevent sunburn.

Water, Cetearyl Alcohol & Cetearyl Glucoside, Cyclopentasiloxane, Isohexadecane, Stearate & Peg-100 stearate, Glycerin, Simmondsia Chimensis (Jojoba) seed oil, Butyrospermum Parkii (shea) Butter, Potassim Cetyl Phosphate, Niacinamide (Vit.B3), Dehydroacetic Acid & Benzoic Acid & Phenoxyethanol, Dimethicone, Maris Sal (from dead sea), * Fragrance (supplement) , Allantoin, Aloe Barbadensis (Aloe Vera) Leaf extract, Retinyl Palmitate, Persea Grattissima, Olea Europaea (Olive) fruit oil, Tocopheryl Acetate (vit.E), Panthenol (vit. B5), Anthemis Nobilis (Chamomile) extract, Punica Granatum (Pomegranate) extract, Camelia Sinensis extract.

Smooth on to face

SPA PHARMA ANTI-AGING ACOCADO CREAM SPF 25 LISTING 
octinoxate,octocrylene, octisalate, avobenzone, homosalate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ISOHEXADECANE (UNII: 918X1OUF1E)
GLYCERIN (UNII: PDC6A3C0OX)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
SHEA BUTTER (UNII: K49155WL9Y)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1601-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2016	08/14/2019

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1601)

Revised: 8/2019

Document Id: 90156099-9aad-9bd8-e053-2a95a90abca0

34390-5

Set id: 2ab771d0-25ab-1256-e054-00144ff8d46c

Version: 3

Effective Time: 20190814