HYDRATING LIP BALM SPF 15 SUNSCREEN ASAP- avobenzone, homosalate, octocrylene, octisalate gel

Hydrating Lip Balm SPF 15 sunscreen by

Drug Labeling and Warnings

Hydrating Lip Balm SPF 15 sunscreen 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 3.5%        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.

PRINCIPAL DISPLAY PANEL

asap

the science of beautiful

hydrating lip balm+

with niacinamide +Alpine Rose
protect

SPF 15 SUNSCREEN

10mL/0.34floz

INGREDIENTS AND APPEARANCE

HYDRATING LIP BALM SPF 15 SUNSCREEN  ASAP
avobenzone, homosalate, octocrylene, octisalate gel

Product 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)