Label: SPA PHARMA OLIVE OIL MOISTURIZING CREAM- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69435-1604-1 - Packager: Peer Pharma Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 23, 2016
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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INDICATIONS & USAGE
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.
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
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.
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INGREDIENTS AND APPEARANCE
SPA PHARMA OLIVE OIL MOISTURIZING CREAM
octinoxate, octocrylene, octisalate, avobenzone, homosalate cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1604 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 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:69435-1604-1 50 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/09/2016 Labeler - Peer Pharma Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharma Ltd. 514678390 manufacture(69435-1604)
