Spa Pharma BB Cream SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

SPA PHARMA BB CREAM SPF 50- homosalate, octisalate, octinoxate, octocrylene, avobenzone, titanium dioxide 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 BB 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, Cetearyl Alcohol & Cocoglucoside, Isopropyl Myristate, Cetyl Alcohol, Propylene Glycol, Decyl Oleate, Potassium Cetyl Phosphate, Nylon-12, Dehydroacetic Acid & Benzoic Acid & Benzyl Alcohol, Dimethicone, *Fragrance, Allantoin, Aloe Barbadensis (Aloe) Leaf Juice, Tocopherol & Lecithin & Ascorbyl Palmitate & Glyceryl Stearate & Glyceryl Oleate, Citric Acid, CI 77491, CI 77492, CI 77499, CI 77288

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 BB CREAM SPF 50 
homosalate, octisalate, octinoxate, octocrylene, avobenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1605
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DECYL OLEATE (UNII: ZGR06DO97T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
NYLON-12 (UNII: 446U8J075B)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1605-1	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 Pharma Ltd. (514678390)

Registrant - Peer Pharma Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharma Ltd.		514678390	manufacture(69435-1605)

Revised: 8/2019

Document Id: 90155d30-7c2a-9d34-e053-2a95a90ac539

34390-5

Set id: 804659c1-43e7-456b-a87c-e7b28a7e7c89

Version: 3

Effective Time: 20190814