Label: OUTBACK 2 IN 1 PROTECTION- octinoxate,avobenzone and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69594-005-01 - Packager: Ultra Mix (Aust) Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 16, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Inactives
- Purpose
- Directions of Usage
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Warnings
For external use only.
When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if a rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact the Poison Control Center immediately.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially between 10 a.m – 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor
- Product Label
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INGREDIENTS AND APPEARANCE
OUTBACK 2 IN 1 PROTECTION
octinoxate,avobenzone and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69594-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 13 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 95 mg in 1 mL Inactive Ingredients Ingredient Name Strength TEA TREE OIL (UNII: VIF565UC2G) EUCALYPTUS POLYBRACTEA LEAF OIL (UNII: J1XGA6WROO) CITRONELLA OIL (UNII: QYO8Q067D0) LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3) Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69594-005-01 75 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/16/2015 Labeler - Ultra Mix (Aust) Pty Ltd (752254649) Establishment Name Address ID/FEI Business Operations Ultra Mix (Aust) Pty Ltd 752254649 manufacture(69594-005) , label(69594-005)