Moisturizer Cream SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

SPA PHARMA MOISTURIZER CREAM SPF 50- homosalate, octisalate, octocrylene, avobenzone, titanium dioxide 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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Moisturizer Cream SPF 50

Octinoxate 7.5%
Octocrylene 5%
Octisalate 5%
Avobenzone 3%
Homosalate 10%

Titanium Dioxide 3%

Keep out of reach of children.

Provides SPF 50 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.

Water, Polyglyceryl-10 Pentastearate & Behenyl Alcohol & Sodium Stearoyl Lactylate, Propylene Glycol, Cetyl Alcohol, Potassium Cetyl Phosphate, Dimethicone, Nylon-12, Dehydroacetic Acid & Benzoic Acid & Benzyl Alcohol, *Fragrance, Aloe Barbadensis (Aloe) Leaf Juice, Allantoin, Citric Acid, Tocopherol & Lecithin & Ascorbyl Palmitate & Glyceryl Stearate & Glyceryl Oleate.

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.

Smooth on to face.

SPA PHARMA MOISTURIZER CREAM SPF 50 
homosalate, octisalate, octocrylene, avobenzone, titanium dioxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
NYLON-12 (UNII: 446U8J075B)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL OLEATE (UNII: 4PC054V79P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1602-1	80 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/24/2016	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(69435-1602)

Revised: 8/2019

Document Id: 90157e94-bfd2-3ffc-e053-2995a90a13ff

34390-5

Set id: 2b5841ca-8387-2f5c-e054-00144ff88e88

Version: 2

Effective Time: 20190814