SHEER TINT MOISTURIZER SPF 15 ASAP SKIN PRODUCTS- titanium dioxide, zinc oxide lotion 
AUSTRALIAN SKIN PRODUCTS PTY 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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Sheer Tint Moisturizer SPF 15

Active Ingredients Purpose

Titanium Dioxide 4% Sunscreen
Zinc Oxide 1% Sunscreen

Uses: Help protect against sunburn

Keep out of reach of children

Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of eyes.

For external use only.
Rinse with water to remove.
If swallowed, get medical help or contact a poison control center right away.

Directions
Apply to clean face. smooth onto face and neck until thoroughly absorbed. Use daily as a base under make up.
Children under 6 months of age: ask a doctor.

Inactive Ingredients: Water (Aqua), Caprylic/capric triglyceride, butylene glycol, Methyl Gluceth-20, Ethylhexyl methoxycinnamate, Titanium Dioxide, Cetearyl Alcohol, Propylene glycol, glyceryl stearate, PEG-100 stearate, triacontanyl PVP, dimethicone, zinc oxide, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, Isobutylparaben, silica, citrus reticulata (tangerine) peel oil, camellia sinensis (white tea) leaf extract, punica granatum (pomegranate) fruit extract, polysorbate 20, Iron oxides (CI 77491, CI77492, CI77499).

image of back labelimage of front label

Sheer tint moisturizer SPF 15
With antioxidants

broad spectrum
Sunscreen lotion
UVA+UVB protection

75 mL/2.54fl oz

SHEER TINT MOISTURIZER SPF 15  ASAP SKIN PRODUCTS
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76261-250
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
BANCHA TEA LEAF/TWIG (UNII: EWI42IEH1C)  
POMEGRANATE (UNII: 56687D1Z4D)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76261-250-0175 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/02/2011
Labeler - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
Registrant - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
Establishment
NameAddressID/FEIBusiness Operations
Natural Beauty Care Pty Ltd749369716manufacture(76261-250)

Revised: 2/2013
Document Id: 73e7910d-2bc1-4a68-8218-1b7994190391
Set id: 73031757-1e54-4c13-a759-209a3dd4dc73
Version: 4
Effective Time: 20130208
 
AUSTRALIAN SKIN PRODUCTS PTY LTD