ASAP SKIN PRODUCTS MOISTURISING DAILY DEFENSE SPF 30- octocrylene, zinc oxide, avobenzone, ensulizole and titanium dioxide 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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Active ingredients Purpose

Octocrylene 6% Sunscreen
Zinc Oxide 2.72% Sunscreen
Avobenzone 2% Sunscreen
Ensulizole 1.5% Sunscreen
Titanium Dioxide 1% Sunscreen


Use: helps prevent against sunburn

Keep out of reach of children

Stop use if rash or irritation develops and lasts. Keep out of eyes. Rinse with water to remove.


Warnings. External use only.
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. Children under 6 months of age: ask a doctor.

Inactive ingredients: Water (aqua), Octocrylene, Niacinamide, C12-15 Alkyl Benzoate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Caprylic/Capric triglyceride, Butyl methoxydibenzoylmethane, phenyl trimethicone, polysorbate 20,sorbitan stearate, cetearyl alcohol, phenoxyethanol, glycerin, dimethicone, Tricontanyl PVP, sodium hyaluronate, tocopheryl acetate, methylparaben, glyceryl isostearate, Citrus tangerina (tangerine) peel oil, sodium hydroxide, polyhydroxystearic acid, Beta carotene, 0.1% solution in olive oil, propylparaben, disodium EDTA, Butylparaben, Xanthan Gum.

image of back label

image of front label


Moisturising daily defense SPF 30+

With antioxidants

Broad spectrum
sunscreen lotion
UVA +UVB protection

100mL 3.38fl oz.

ASAP SKIN PRODUCTS  MOISTURISING DAILY DEFENSE SPF 30
octocrylene,zinc oxide, avobenzone, ensulizone, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76261-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE6 mL  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE2.75 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE2 mL  in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE1.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
OCTOCRYLENE 
NIACINAMIDE 
ALKYL (C12-15) BENZOATE 
C13-14 ISOPARAFFIN 
LAURETH-7 
MEDIUM-CHAIN TRIGLYCERIDES 
AVOBENZONE 
PHENYL TRIMETHICONE 
POLYSORBATE 20 
SORBITAN MONOSTEARATE 
CETOSTEARYL ALCOHOL 
PHENOXYETHANOL 
GLYCERIN 
DIMETHICONE 
HYALURONATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLPARABEN 
GLYCERYL ISOSTEARATE 
CITRUS RETICULATA FRUIT OIL 
SODIUM HYDROXIDE 
POLYHYDROXYSTEARIC ACID (2300 MW) 
PROPYLPARABEN 
EDETATE DISODIUM 
BUTYLPARABEN 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:76261-125-01100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/03/2011
Labeler - Australian Skin Products pty ltd (752403019)
Registrant - Cosmetic Manufacturers (Aust) Pty (758742308)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Manufacturers (Aust) Pty758742308manufacture(76261-125)

Revised: 09/2012
Document Id: b8fa3caf-68ac-497e-bc95-7f9d4323a2c3
Set id: d3fa4643-e69e-4db9-8826-a6c46a712996
Version: 1
Effective Time: 20120905
 
Australian Skin Products pty ltd