SPF 15 LIP CONDITIONER- avobenzone, homosalate, octinoxate, octocrylene cream
OJAS, 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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Active Ingredients:

Avobenzone - 3%

Homosalate - 5%

Octinoxate - 5%

Octocrylene - 2.75%

Purpose: Sunscreen

Uses:

Helps protect against sunburn and chapped lips.

Warnings:

Stop use and ask a doctor if rash occurs.

Directions:

Apply generously before sun exposure and as needed.

Inactive Ingredients:

Simmondsia Chinensis (Jojoba) Seed Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Palmitate, Organic Persea Gratissima (Avocado) Oil, Dipalmitoyl Hydroxyproline, Flavor, Tetrahexyldecyl Ascorbate, Butylene/Ethylene/Styrene Copolymer, Tocopheryl Acetate, Tribehenin, Sorbitan Isostearate, Lecithin, Caprylic/Capric Triglyceride, Physalis Angulata, Extract, Leontopodium Alpinum Meristem Cell Culture, Silica Dimethyl Silylate, Polygonum Aviculare Extract, Butylene Glycol, Sodium Hyaluronate, Water, Glycerin, Palmitoyl Tripeptide-1, Citrus Aurantium Dulcis (Orange) Callus Culture Extract, Xanthan Gum.

Made In USA

Distributed By OJAS, LLC

OjasSkin.Com

image description

SPF 15 LIP CONDITIONER
avobenzone, homosalate, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70867-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.0 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50.0 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50.0 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
JOJOBA OIL (UNII: 724GKU717M)
STYRENE (UNII: 44LJ2U959V)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
AVOCADO OIL (UNII: 6VNO72PFC1)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
1-BUTENE (UNII: LY001N554L)
ETHYLENE (UNII: 91GW059KN7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWER (UNII: MWN6IZU3XM)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
CITRUS SINENSIS FLOWER (UNII: H02N5LQ5F6)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70867-102-11	2 mL in 1 TUBE; Type 0: Not a Combination Product	11/17/2015
2	NDC:70867-102-52	1 in 1 CARTON	11/17/2015
2	NDC:70867-102-12	7.5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/17/2015

Labeler - OJAS, LLC (080118329)

Registrant - OJAS, LLC (080118329)