HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP- avobenzone, homosalate, octocrylene, octisalate gel 
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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hydrating lip balm SPF 15 Sunscreen

Active Ingredients        Purpose


Avobenzone 3.5%        Sunscreen

Homosalate 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 skin

When 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.

asap

the science of beautiful

hydrating lip balm+

with niacinamide +Alpine Rose
protect

SPF 15 SUNSCREEN

10mL/0.34floz

Box

HYDRATING LIP BALM SPF 15 SUNSCREEN  ASAP
avobenzone, homosalate, octocrylene, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76261-127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76261-127-021 in 1 CARTON
1NDC:76261-127-0110 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/07/2014
Labeler - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
Registrant - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
Establishment
NameAddressID/FEIBusiness Operations
Natural Beauty Care Pty Ltd749369716manufacture(76261-127)

Revised: 8/2014
Document Id: 76039001-5295-415d-9010-930f5019b7a7
Set id: bafadc36-5019-4f18-a4fd-85f8d4a70053
Version: 1
Effective Time: 20140807
 
AUSTRALIAN SKIN PRODUCTS PTY LTD