SUNSCREEN 100- titanium dioxide cream

Sunscreen 100 by

Drug Labeling and Warnings

Sunscreen 100 by is a Otc medication manufactured, distributed, or labeled by CMS LAB Inc., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titamiun Dioxdie (2.52%)

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body

- do not use on damaged or broken skin

- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Directions

- Apply the adequate amount onto the entire face at the last stage of your skin care routine.

Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.

- Apply liberally 15 minutes before sun exposure.

- Reapply at least every 2 hours.

- Use a water-resistant sunscreen if swimming or sweating.

- Children under 6 months of age: ask a doctor

Inactive ingredients

WATER, DIBUTYL ADIPATE, POLYGLYCERYL-2 CAPRATE, SUCROSE STEARATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, SQUALANE, GLYCERIN, C12-15 ALKYL BENZOATE, PROPANEDIOL, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, PORTULACA OLERACEA EXTRACT, BUTYLOCTYL SALICYLATE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, ARACHIDYL GLUCOSIDE, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL TRIAZONE, CETEARYL ALCOHOL, SACCHARIDE HYDROLYSATE, SALVIA HISPANICA SEED EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, GLYCERYL STEARATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL, PANTHENOL, SODIUM STEAROYL GLUTAMATE, POLYACRYLATE CROSSPOLYMER-6, t-BUTYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, XANTHAN GUM, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, PALMITIC ACID, CHOLESTERYL MACADAMIATE, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN

Sunscreen 100

INGREDIENTS AND APPEARANCE

SUNSCREEN 100 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52554-1111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.26 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SQUALANE (UNII: GW89575KF9)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPANEDIOL (UNII: 5965N8W85T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DOCOSANOL (UNII: 9G1OE216XY)
PURSLANE (UNII: M6S840WXG5)
POLYSILICONE-15 (UNII: F8DRP5BB29)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SACCHARIDE HYDROLYSATE (UNII: ED959S6ACY)
CHIA SEED (UNII: NU0OLX06F8)
TURMERIC (UNII: 856YO1Z64F)
WATER (UNII: 059QF0KO0R)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
SUCROSE STEARATE (UNII: 274KW0O50M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52554-1111-2	1 in 1 PACKAGE	10/19/2017
1	NDC: 52554-1111-1	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/19/2017

Labeler - CMS LAB Inc. (557795012)

Registrant - CMS LAB Inc. (557795012)

Establishment
Name	Address	ID/FEI	Business Operations
CMS LAB Inc.		557795012	relabel(52554-1111)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(52554-1111)