SPA PHARMA OLIVE OIL MOISTURIZING CREAM- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream

Spa Pharma Olive Oil Moisturizing Cream by

Drug Labeling and Warnings

Spa Pharma Olive Oil Moisturizing Cream by is a Otc medication manufactured, distributed, or labeled by Peer Pharma Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octocrylene 5%

Octisalate 5%

Octinoxate 7.5%

Avobenzone 3%

Homosalate 2%

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Provides SPF 25 protection

Skin moisturizer

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

Smooth on to face

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPA PHARMA OLIVE OIL MOISTURIZING CREAM 
octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream

Product 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)