A24 NATURALISM SENSITIVE SKIN SUNSCREEN SPF 50- titanium dioxide and zinc oxide cream 
Orange Lab

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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A24 Naturalism Sensitive Skin Sunscreen SPF 50 PA++++

OTC Active Ingredient

active in

Purpose

Active/Purpose

Uses

Uses

Warnings

Warning

Directions

Direections

Sun Protection Mesaures

Sun Protection Measures

KEEP OUT OF REACH OF CHILDREN

Keep out of reach children

Inactive Ingredients

Inactive ingredients

Other information - Safety storage, etc.

Other information

Questions or comments

questions or comments

Principal Display Panel

Tube front display

Package - outer box

Package outer box

A24 NATURALISM SENSITIVE SKIN SUNSCREEN SPF 50 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71331-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.88 g  in 60 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.7 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
ADENOSINE (UNII: K72T3FS567)  
PROPANEDIOL (UNII: 5965N8W85T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ROSEMARY (UNII: IJ67X351P9)  
SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE 20 (UNII: H8YMB5QY0D)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
ALLANTOIN (UNII: 344S277G0Z)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71331-109-021 in 1 BOX07/12/2021
1NDC:71331-109-0160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/12/2021
Labeler - Orange Lab (004862271)
Registrant - Orange Lab (004862271)
Establishment
NameAddressID/FEIBusiness Operations
Orange Lab004862271manufacture(71331-109)

Revised: 1/2023
Document Id: f1f09ca2-53e5-60e7-e053-2995a90aa2e3
Set id: c68fa38a-8d89-67c4-e053-2995a90a769f
Version: 2
Effective Time: 20230110
 
Orange Lab