SHEER TINT MOISTURIZER SPF 15 ASAP SKIN PRODUCTS- titanium dioxide, zinc oxide lotion

Sheer Tint Moisturizer SPF 15 by

Drug Labeling and Warnings

Sheer Tint Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by AUSTRALIAN SKIN PRODUCTS PTY LTD, Natural Beauty Care Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

Sheer tint moisturizer SPF 15
With antioxidants

broad spectrum
Sunscreen lotion
UVA+UVB protection

75 mL/2.54fl oz

INGREDIENTS AND APPEARANCE

SHEER TINT MOISTURIZER SPF 15  ASAP SKIN PRODUCTS
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76261-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76261-250-01	75 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/02/2011

Labeler - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)

Registrant - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Beauty Care Pty Ltd		749369716	manufacture(76261-250)