HYDRATING LIP BALM SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene gel

HYDRATING LIP BALM SUNSCREEN by

Drug Labeling and Warnings

HYDRATING LIP BALM SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 2.7%

Purpose

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

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.

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply generously and evenly to lips 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 value of 15 or higher and other sun protection measures including:

    limit time in the sun, especially from 10 a.m.- 2p.m.

    wear long-sleeved shirts, pants, hats and sunglasses

 children under 6 months of age: Ask a doctor

Inactive ingredients

Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Bis-Diglyceryl Polyacyladipate-2, Caprylic/Capric Triglyceride, Beeswax, Ozokerite, Polyisobutene, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Flavor, Dipotassium Glycyrrhizate, Vaccinium Myrtillus Seed Oil, Alcohol, Water (Aqua), Glycerin, Zanthoxylum Bungeanum Fruit Extract, Sarracenia Leucophylla Flower/Leaf/Seed/Stalk Extract, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Hypericum Perforatum Flower/Leaf Extract, Camellia Sinensis Leaf Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Sodium Lauroyl Lactylate, Melissa Officinalis Extract, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Xanthan Gum, Carbomer, Ceramide EOP

Other information

protect the product in this container from excessive heat and direct sun

Questions or comments?

Call Toll-Free 1-844-My-Aubio (1-844-692-8246)

Monday-Friday 9am-5pm ET

SPL UNCLASSIFIED SECTION

UVA/UVB Protection

BROAD STECTRUM SPF 30

moisturizes and conditions dry lips

AubioTM Hydrating Lip Balm provides BROAD STECTRUM SPF 30 protection while moisturizing and conditioning dry lips

Aubio Life SciencesTM

www.aubio.com

Patent Pending

Distributed by Aubio Life Sciences, LLC

Wixom, MI 48393

Packaging

INGREDIENTS AND APPEARANCE

HYDRATING LIP BALM SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61383-248
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WHITE WAX (UNII: 7G1J5DA97F)
CERESIN (UNII: Q1LS2UJO3A)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
BILBERRY SEED OIL (UNII: KK0KHX972K)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
SARRACENIA PURPUREA (UNII: FOP08H143P)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
LICORICE (UNII: 61ZBX54883)
ST. JOHN'S WORT (UNII: UFH8805FKA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ELEUTHERO (UNII: ZQH6VH092Z)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
MELISSA OFFICINALIS (UNII: YF70189L0N)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61383-248-01	1 in 1 BLISTER PACK	04/23/2018
1	NDC: 61383-248-15	4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/23/2018

Labeler - Dimensional Merchandising Inc. (076693183)