Spa Pharma Day Defense Moisturizing Cream SPF 25

Drug Labeling and Warnings

Drug Details [pdf]

SPA PHARMA DAY DEFENSE MOISTURIZING CREAM- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream 
Peer Pharma 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 Day Defense Moisturizing Cream SPF 25

Octinoxate 7.5%

Octocrylene 5%

Octisalate 5%

Avobenzone 3%

Homosalate 2%

Keep out of reach of children.

Provides SPF 25 protection

To Use: Smooth onto face.
For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses.

Smooth on to face.

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.

SPA PHARMA DAY DEFENSE MOISTURIZING CREAM 
octinoxate, octocrylene, octisalate, avobenzone, homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1609
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
GLYCERIN (UNII: PDC6A3C0OX)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
SHEA BUTTER (UNII: K49155WL9Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SEA SALT (UNII: 87GE52P74G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
CAMELINA SATIVA WHOLE (UNII: W42JFE4HON)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1609-1	50 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/23/2016	08/14/2019

Labeler - Peer Pharma Ltd. (514678390)

Registrant - Peer Pharma Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharma Ltd.		514678390	manufacture(69435-1609)

Revised: 8/2019

Document Id: 90157e94-bfaa-3ffc-e053-2995a90a13ff

34390-5

Set id: 2ecc93dc-d575-71c4-e054-00144ff8d46c

Version: 3

Effective Time: 20190814