OS-01 BODY SPF 30- zinc oxide cream 
Allure Labs

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Drug Facts

Active ingredients – Zinc Oxide 14 %

Purpose – Sunscreen

Uses –

Helps prevent sunburn
If used as directed with other sun protection measures (See direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Warning – For external use only

Do not use on damaged or broken skin

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

Stop use and ask doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Direction-

Apply liberally 15 minutes before sun exposure.
Reapply after 80 minutes of swimming or sweating.
immediately after towel drying, at least every 2 hours
Children under 6 months of age: Ask a doctor.
Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:
Limit time in the sun. especially from 10 am to 2 pm
Wear long-sleeved shirts, pants hats and sunglasses.

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

Inactive Ingredients: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.

Body SPF 30

OS-01 BODY SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4264
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
SHEANUT (UNII: 84H6HBP32L)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
CAMELLIA OIL (UNII: T1PE06G0VE)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MALPIGHIA EMARGINATA SEED (UNII: 1X7L93686M)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
C13-15 ALKANE (UNII: 114P5I43UJ)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4264-21 in 1 CARTON06/20/2024
1NDC:62742-4264-1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/20/2024
Labeler - Allure Labs (926831603)
Registrant - Allure LAbs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4264)

Revised: 6/2024
Document Id: 1b582f4e-5540-a511-e063-6294a90af3c0
Set id: 1b582f4e-553f-a511-e063-6294a90af3c0
Version: 1
Effective Time: 20240620
 
Allure Labs