Label: HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP- avobenzone, homosalate, octocrylene, octisalate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76261-127-01, 76261-127-02 - Packager: AUSTRALIAN SKIN PRODUCTS 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 August 7, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3.5% SunscreenHomosalate 5.0% Sunscreen
Octocrylene 5.0% Sunscreen
Octisalate 5.0% Sunscreen
Uses: Helps prevent sunburn and chapped lips. 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 skinWhen using this product keep out of eyes. Rinse with water to remove
Directions
Apply Liberally to lips as often as desired
Apply liberally 15 minutes before sun exposure
Reapply: at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Sun Protectection 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 skin protection measures including:
- Limit time in the sun especially from 10 a.m. -2 p.m.
- Wear long-sleeve shirts, pants, and sunglasses
- Children under 6 months ask a doctor
Hydrogenated Polysiobutene, Ethylene/Propylene/Styrene Copolymer, Nicinamide, Rohododendron Ferruineum (Alpine Rose) Extract, Tricaprylin, Polyamide-3, Ethyl Macadamiate, Bisabolol, Tocopherol, Zingiber Officinale (Ginger) Root Extract, Glycerin, Malic Acid, Citrus Reticulata (Tangerine) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Medica Limonium (Lemon) peel Oil, Ethyl Methylphenylglycidate, Butylene/Ethylene/Styrene Copolymer, BHT,limonene.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP
avobenzone, homosalate, octocrylene, octisalate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76261-127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) NIACINAMIDE (UNII: 25X51I8RD4) TRICAPRYLIN (UNII: 6P92858988) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) TOCOPHEROL (UNII: R0ZB2556P8) GINGER (UNII: C5529G5JPQ) MALIC ACID (UNII: 817L1N4CKP) MANDARIN OIL (UNII: NJO720F72R) GRAPEFRUIT OIL (UNII: YR377U58W9) BERGAMOT OIL (UNII: 39W1PKE3JI) LEMON OIL (UNII: I9GRO824LL) ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LIMONENE, (+)- (UNII: GFD7C86Q1W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76261-127-02 1 in 1 CARTON 1 NDC:76261-127-01 10 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/07/2014 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(76261-127)
