SPF 30 MINERAL SUNSCREEN FACE NECK- zinc oxide cream

SPF 30 MINERAL SUNSCREEN FACE NECK by

Drug Labeling and Warnings

SPF 30 MINERAL SUNSCREEN FACE NECK 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:

ZINC OXIDE 18.6%   

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• High protection against sunburn.
• Higher SPF gives more sunburn protection.
  

WARNINGS

Warnings: For external use only.

WHEN USING

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

ASK DOCTOR

Stop use ans ask a doctor if rash occurs.

DO NOT USE

Do not use on damaged or broken skin.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions:

• Apply generously 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply as needed or after towel drying, swimming or perspiring.
• children under 6 months of age: ask a doctor.
  

STORAGE AND HANDLING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 30 MINERAL SUNSCREEN FACE NECK 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70867-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	15 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70867-104-52	1 in 1 CARTON	07/26/2016
1	NDC: 70867-104-11	50 mL 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 final	part352	07/26/2016

Labeler - OJAS, LLC (080118329)

Registrant - OJAS, LLC (080118329)