CORRECTING CREAM BROAD SPECTRUM SPF 15 ASAP- avobenzone, octinoxate, octocrylene, oxybenzone, zinc oxide lotion

correcting cream Broad Spectrum SPF 15 by

Drug Labeling and Warnings

correcting cream Broad Spectrum 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

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).

PRINCIPAL DISPLAY PANEL

asap

the science of beautiful skin
correcting cream

with antixidants

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

INGREDIENTS AND APPEARANCE

CORRECTING CREAM BROAD SPECTRUM SPF 15  ASAP
avobenzone, octinoxate, octocrylene, oxybenzone, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76261-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76261-126-02	1 in 1 BOX
1	NDC: 76261-126-01	75 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/04/2014

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(76261-126)