H SKIN REPAIR - HYDRATE PLUS RESTORE SUNSCREEN SPF30 PLUS BLEMISH FIX TINTED MINERAL MAKEUP- octinoxate and zinc oxide cream

H Skin Repair - Hydrate plus Restore Sunscreen SPF30 plus Blemish Fix Tinted Mineral Makeup by

Drug Labeling and Warnings

H Skin Repair - Hydrate plus Restore Sunscreen SPF30 plus Blemish Fix Tinted Mineral Makeup by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

Octyl Methoxycinnamate 7.5%, Zinc Oxide 7.0%.

PURPOSE

Sunscreen

USES

Help prevent sunburn.

WARNINGS

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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen.

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 value 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-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS

Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone, Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/ Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, Iron Oxides (Cl77491), (Cl77492) (Cl77499).

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

H
skin repair

HYDRATE + RESTORE

sunscreen spf 30+blemish fix
tinted mineral makeup cream

with 7% zinc oxide, natural beeswax
& natural carnauba

helps heal blemishes + redness + repair damaged + dry skin

1 FLUID OUNCE (30mL)

INGREDIENTS AND APPEARANCE

H SKIN REPAIR - HYDRATE PLUS RESTORE SUNSCREEN SPF30 PLUS BLEMISH FIX TINTED MINERAL MAKEUP 
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-7622
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Glyceryl Dilaurate (UNII: MFL3ZIE8SK)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Yellow Wax (UNII: 2ZA36H0S2V)
Dimethicone (UNII: 92RU3N3Y1O)
Cyclomethicone (UNII: NMQ347994Z)
Diisopropyl Adipate (UNII: P7E6YFV72X)
Hexylene Glycol (UNII: KEH0A3F75J)
PEG-40 Stearate (UNII: ECU18C66Q7)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
Carnauba Wax (UNII: R12CBM0EIZ)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
Sorbitan Tristearate (UNII: 6LUM696811)
Stearoxytrimethylsilane (UNII: 9862TW94B2)
Steareth-100 (UNII: 4OH5W9UM87)
Laureth-7 (UNII: Z95S6G8201)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-7622-1	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2019

Labeler - Cosmetic Solutions LLC (807907928)