SPF 30 BODY SUNSCREEN- avobenzone,octinoxate, octisalate, octocrylene, oxybenzone cream 
Alure Labs, Inc.

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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Drug Facts

Active Ingredients:

Avobenzone - 2%

Octinoxate - 7.5%

Octisalate - 5%

Octocrylene - 1.5%

Oxybenzone - 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), 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.

Made in USA

Distributed By OJAS, LLC

OjasSkin.com

image description

SPF 30 BODY SUNSCREEN 
avobenzone,octinoxate, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4079
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:62742-4079-21 in 1 CARTON
1NDC:62742-4079-1120 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/03/2015
Labeler - Alure Labs, Inc. (926831603)

Revised: 11/2015
Document Id: d05521b6-c493-4d14-9675-e0a6d0a68143
Set id: 9f1523f3-48b2-450d-88ff-65d67b67776d
Version: 1
Effective Time: 20151103
 
Alure Labs, Inc.