Label: A24 NATURALISM SENSITIVE SKIN SUNSCREEN SPF 50- titanium dioxide and zinc oxide cream
- NDC Code(s): 71331-109-01, 71331-109-02
- 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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INGREDIENTS AND APPEARANCE
A24 NATURALISM SENSITIVE SKIN SUNSCREEN SPF 50
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71331-109 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71331-109-02 1 in 1 BOX 07/12/2021 1 NDC:71331-109-01 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 07/12/2021 Labeler - Orange Lab (004862271) Registrant - Orange Lab (004862271) Establishment Name Address ID/FEI Business Operations Orange Lab 004862271 manufacture(71331-109)
