ENFANTI DERMA SERIES 100% MINERAL SUN SHIELD- 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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Enfanti Derma Series SPF 50 PA++++ 1.8 fl oz.

Active ingredients

Active Ingredients

Purpose

Purpose

Uses

Uses

Do not use / Warnings

Warning and Do not use

Directions :

Directions

Sun Protection Measures

Sun Protection Measures

Keep out of reach of children

Keep out or reach of children

Inactie ingredients

Inactive ingredients

Other information - Safety Sotarge, etc.

Other info

Package front display panel

Label front

Outer box artwork

outer box

ENFANTI DERMA SERIES 100% MINERAL SUN SHIELD 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71331-110
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ALLANTOIN (UNII: 344S277G0Z)  
ROSEMARY (UNII: IJ67X351P9)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE 20 (UNII: H8YMB5QY0D)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
PROPANEDIOL (UNII: 5965N8W85T)  
NIACINAMIDE (UNII: 25X51I8RD4)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ADENOSINE (UNII: K72T3FS567)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71331-110-021 in 1 BOX12/29/2021
1NDC:71331-110-0160 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 finalpart35212/29/2021
Labeler - Orange Lab (004862271)
Registrant - Orange Lab (004862271)
Establishment
NameAddressID/FEIBusiness Operations
Orange Lab, Inc.004862271manufacture(71331-110)

Revised: 1/2023
Document Id: f1f09ca2-53e7-60e7-e053-2995a90aa2e3
Set id: d44d42af-cd23-7058-e053-2995a90ad66e
Version: 2
Effective Time: 20230110
 
Orange Lab