Label: ENFANTI DERMA SERIES 100% MINERAL SUN SHIELD- titanium dioxide and zinc oxide cream
- NDC Code(s): 71331-110-01, 71331-110-02
- Packager: Orange Lab
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 10, 2023
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- Official Label (Printer Friendly)
- 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
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INGREDIENTS AND APPEARANCE
ENFANTI DERMA SERIES 100% MINERAL SUN SHIELD
titanium dioxide and zinc oxide creamProduct 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)
