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

SPF 15 Lip Conditioner by

Drug Labeling and Warnings

SPF 15 Lip Conditioner by is a Otc medication manufactured, distributed, or labeled by OJAS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Avobenzone - 3%

Homosalate - 5%

Octinoxate - 5%

Octocrylene - 2.75%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• Helps protect against sunburn and chapped lips.
  

WARNINGS

Warnings:

Stop use and ask a doctor if rash occurs.

WHEN USING

Directions:

• Apply generously before sun exposure and as needed.
  

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Made In USA

Distributed By OJAS, LLC

OjasSkin.Com

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/17/2015

Labeler - OJAS, LLC (080118329)

Registrant - OJAS, LLC (080118329)