CORRECTING CREAM BROAD SPECTRUM SPF 15 ASAP- avobenzone, octinoxate, octocrylene, oxybenzone, 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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CC cream Broad Spectrum SPF 15

Active ingredients          Purpose

Avobenzone 3%            Sunscreen

Octinoxate 4%              Sunscreen

Oxybenzone 3%            Sunscreen

Zinc Oxide 4.5%            Sunscreen

Uses: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out eye. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure

Reapply: at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk , regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:

Limit time in the sun especially from 10 a.m. - 2 p.m.

Wear long-sleeve Shirts, pants, hats and sunglasses

children under 6 months ask a doctor

Inactive ingredients: Water (Aqua), Methyl Gluceth-20, Caprylic/Capric Triglyceride, Butylene Glycol, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Triacontanyl PVP, Dimethicone, Citrus Tangerina (Tangerine) Peel Oil, Camellia Sinensis Leaf Extract, Punica Granatum (Pomegranate) Fruit Extract, Phenoxyethanol, Benzyl Alcohol, Triethanolamine, Ethylhexylglycerin, Propylene Glycol, Polysorbate 20, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499).

asap

the science of beautiful skin
correcting cream

with antixidants

hydrate + protect
Broad Spectrum SPF 15 sunscreen
75 mL/ 2.54 fl oz

Box image

CORRECTING CREAM BROAD SPECTRUM SPF 15  ASAP
avobenzone, octinoxate, octocrylene, oxybenzone, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76261-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MANDARIN OIL (UNII: NJO720F72R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
POMEGRANATE (UNII: 56687D1Z4D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TROLAMINE (UNII: 9O3K93S3TK)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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:76261-126-021 in 1 BOX
1NDC:76261-126-0175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/04/2014
Labeler - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
Registrant - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
Establishment
NameAddressID/FEIBusiness Operations
Natural Beauty Care Pty Ltd749369716manufacture(76261-126)

Revised: 8/2014
Document Id: 56f3b078-ed8d-4b8b-9214-43644b68b2b0
Set id: a18efbfc-0f29-4a51-87b1-eaa5dc94f8e0
Version: 1
Effective Time: 20140804
 
AUSTRALIAN SKIN PRODUCTS PTY LTD