SPF 30 BODY SUNSCREEN- avobenzone,octinoxate, octisalate, octocrylene, oxybenzone cream

SPF 30 Body Sunscreen by

Drug Labeling and Warnings

SPF 30 Body Sunscreen 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 - 2%

Octinoxate - 7.5%

Octisalate - 5%

Octocrylene - 1.5%

Oxybenzone - 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 INGREDIENT

Inactive Ingredients: Water (Aqua), C12-15 Alkyl Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Cyclopentasiloxane, Cyclohexaciloxane, Caprylic/Capric Triglyceride, Glycerin, Sorbitan Oleate, Ubiquinone, Physalis Angulata Extract, Teprenone, Sodium Hyaluronate, Organic Camellia Sinensis Leaf Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Algae Extract, Artemisia Vulgaris Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Palmitoyl Pentapeptide-4, Leontopodium Alpinum Meristem Cell Culture, Plankton Extract, Micrococcus Lysate, Arabidopsis Thaliana Extract, Organic Aloe Barbadensis Leaf Juice, Polygonum Aviculare Extract, Xanthan Gum, Lecithin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Triethanolamine, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Fragrance, Disodium EDTA.

PRINCIPAL DISPLAY PANEL

Made in USA

Distributed By OJAS, LLC

OjasSkin.com

INGREDIENTS AND APPEARANCE

SPF 30 BODY SUNSCREEN 
avobenzone,octinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70867-101
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: 70867-101-52	1 in 1 CARTON	11/03/2015
1	NDC: 70867-101-11	120 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	11/03/2015

Labeler - OJAS, LLC (080118329)

Registrant - OJAS, LLC (080118329)