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

Spa Pharma Moisturizing Cream SPF25

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 69435-1609
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69435-1609-150 mL in 1 CONTAINER; Type 0: Not a Combination Product03/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/23/201608/14/2019
Labeler - Peer Pharma Ltd. (514678390)
Registrant - Peer Pharma Ltd. (514678390)
Establishment
NameAddressID/FEIBusiness Operations
Peer Pharma Ltd.514678390manufacture(69435-1609)

Revised: 8/2019
 

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