MINERALIUM HDRA SOURCE MOISTURIZING PROTECTOR SPF 25- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream

Mineralium Hdra Source Moisturizing Protector SPF 25 by

Drug Labeling and Warnings

Mineralium Hdra Source Moisturizing Protector SPF 25 by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERALIUM HDRA SOURCE MOISTURIZING PROTECTOR SPF 25 
octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1606
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2 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: 69435-1606-1	50 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

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1606)