AUBIO LIFE SCIENCES LIP- homosalate, avobenzone, octisalate and octocrylene lipstick 
Aubio Life Sciences LLC

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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Drug Facts

Active Ingredients

Homosalate 15.00%

Octisalate 5.00%

Avobenzene 3.00%

Octocrylene 2.70%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

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. If swallowed, get medical help or contact a Poison Control Center immediately

Directions

Inactive Ingredients

Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Bis-Diglyceryl Polycyladipate-2, Caprylic/Capric Triglyceride, Beeswax, Ozokerite, Polyisobutene, Copernicia Cerifera (Carnauba Wax), Euphorbia Cerifera (Candelila) Wax, Sarracenia Leucophylla Leaf/Stem/Flower/Seed Extract (and) Sarracenia Purpurea Leaf/Stem/Flower/Seed Extract, Lavandula Augustifolia (Lavender) Flower Extract Melissa Officinalis (Balm Mint) Extract Zanthoxylum Bungeanum Fruit Extract Vaccinium Myrtillus Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Unsaponifiables, Dipotassium Glycyrrtiizate) Phytosphingosine, Ceramide AP, Ceramide EOP, Ceramide NP, Giycerin, Water (Aqua), Cholesterol, Sodium Lauroyi Lactylate, Carbomer, Xantham Gum, Flavor

Other Information

Questions or comments?

Call Toll-free 1 -844-My-Aubío

(1-844-692-8246)

Weekdays 9am-5pm PT. If you are not completely satisfied, save receipt and remaining product and call us.

Principal Display Panel - Blister Pack Label

Aubío

Hydrating Lip Therapy

Broad Spectrum SPF 30 Sunscreen

Nourishing botanical formula

Contains skin lipids for
intense moisturizing

Revitalizes and soothes

NET WT 4.25g (0.15 oz)

Principal Display Panel - Blister Pack Label
AUBIO LIFE SCIENCES LIP 
homosalate, avobenzone, octisalate and octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70365-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate30 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Carbomer Interpolymer Type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
Phytosphingosine (UNII: GIN46U9Q2Q)  
Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
Xanthan Gum (UNII: TTV12P4NEE)  
Cholesterol (UNII: 97C5T2UQ7J)  
Ceramide NP (UNII: 4370DF050B)  
3-DEHYDROXY CERAMIDE 1 (UNII: CR0J8RN66K)  
Ceramide AP (UNII: F1X8L2B00J)  
Shea Butter (UNII: K49155WL9Y)  
Coconut Oil (UNII: Q9L0O73W7L)  
Bis-Diglyceryl Polyacyladipate-2 (UNII: 6L246LAM9T)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Ceresin (UNII: Q1LS2UJO3A)  
Isohexadecane (UNII: 918X1OUF1E)  
Carnauba Wax (UNII: R12CBM0EIZ)  
Candelilla Wax (UNII: WL0328HX19)  
Lavandula Angustifolia Flower (UNII: 19AH1RAF4M)  
Melissa Officinalis (UNII: YF70189L0N)  
Zanthoxylum Bungeanum Fruit (UNII: 3CIP16A418)  
Bilberry Seed Oil (UNII: KK0KHX972K)  
Sunflower Oil (UNII: 3W1JG795YI)  
Sarracenia Purpurea (UNII: FOP08H143P)  
Raspberry (UNII: 4N14V5R27W)  
Mango (UNII: I629I3NR86)  
Cucumber (UNII: YY7C30VXJT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70365-002-014.25 g in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/28/2016
Labeler - Aubio Life Sciences LLC (080080743)
Establishment
NameAddressID/FEIBusiness Operations
KLEEN CONCEPTS012989797MANUFACTURE(70365-002) , LABEL(70365-002)

Revised: 1/2016
Document Id: 1079236a-c2c2-450f-bf61-7960780394c4
Set id: a5f77e92-f166-4c10-bb75-5c81a75d40c8
Version: 1
Effective Time: 20160131
 
Aubio Life Sciences LLC