ENFANTI DERMA SERIES 100% MINERAL SUN SHIELD- titanium dioxide and zinc oxide cream

Enfanti Derma Series 100% Mineral Sun Shield by

Drug Labeling and Warnings

Enfanti Derma Series 100% Mineral Sun Shield by is a Otc medication manufactured, distributed, or labeled by Orange Lab, Orange Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Purpose

Uses

Do not use / Warnings

Directions :

Sun Protection Measures

Keep out of reach of children

Inactie ingredients

Other information - Safety Sotarge, etc.

Package front display panel

Outer box artwork

INGREDIENTS AND APPEARANCE

ENFANTI DERMA SERIES 100% MINERAL SUN SHIELD 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71331-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.88 g  in 60 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.7 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71331-110-02	1 in 1 BOX	12/29/2021
1	NDC: 71331-110-01	60 g 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 not final	part352	12/29/2021

Labeler - Orange Lab (004862271)

Registrant - Orange Lab (004862271)

Establishment
Name	Address	ID/FEI	Business Operations
Orange Lab, Inc.		004862271	manufacture(71331-110)