SPF 30 MINERAL SUNSCREEN FACE NECK- zinc oxide 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:

ZINC OXIDE 18.6%   

Purpose: Sunscreen

Uses:

Warnings: For external use only.

When using this product keep out of eyes. Rinse with to remove.

Stop use ans ask a doctor if rash occurs.

Do not use on damaged or broken skin.

Keep out of reach of children.

Directions:

Protect the product in in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

Water (Aqua), Cycclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyaqcrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice Powder, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.

30030A-OJAS-SPF30FaceNeck-PROOF_cropped

SPF 30 MINERAL SUNSCREEN FACE NECK 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70867-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE15 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
UBIDECARENONE (UNII: EJ27X76M46)  
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)  
TEPRENONE (UNII: S8S8451A4O)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ACTINIDIA CHINENSIS ROOT (UNII: 1L6O0O338I)  
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)  
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70867-104-521 in 1 CARTON07/26/2016
1NDC:70867-104-1150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/26/2016
Labeler - OJAS, LLC (080118329)
Registrant - OJAS, LLC (080118329)

Revised: 7/2016
Document Id: a12592de-cb2a-4c52-9d90-aa131bec7833
Set id: 146dc4c9-83a1-4801-b92f-fe472dfa23df
Version: 2
Effective Time: 20160729
 
OJAS, LLC