SUNSCREEN 100- titanium dioxide cream 
CMS LAB Inc.

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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Sunscreen 100

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

sunscreen100

SUNSCREEN 100 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.26 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52554-1111-21 in 1 PACKAGE10/19/2017
1NDC:52554-1111-150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/19/2017
Labeler - CMS LAB Inc. (557795012)
Registrant - CMS LAB Inc. (557795012)
Establishment
NameAddressID/FEIBusiness Operations
CMS LAB Inc.557795012relabel(52554-1111)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(52554-1111)

Revised: 10/2017
Document Id: 5bec4efd-2512-e6e1-e053-2a91aa0af4df
Set id: 5bec4efd-2511-e6e1-e053-2a91aa0af4df
Version: 3
Effective Time: 20171019
 
CMS LAB Inc.