Label: DR. BARBARA STURM MOLECULAR COSMETICS SPF 50 SUNSCREEN- homosalate, octinoxate, octisalate, avobenzone liquid
- NDC Code(s): 83175-232-10, 83175-232-30
- Packager: Barbara Sturm Molecular Cosmetics GmbH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 28, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply every 2 hours
• children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats and sunglasses -
Inactive Ingredients
Aqua/Water/Eau, Butyloctyl Salicylate, Glycerin, Styrene/Acrylates Copolymer, Potassium Cetyl Phosphate, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Portulaca Oleracea (Purslane) Extract, Phenoxyethanol, Tocopherol Acetate, Polyacrylate-13, Xanthan Gum, Pentylene Glycol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Sodium Hyaluronate, Polyisobutene, Polysorbate 20, Panthenol, Arginine, Sodium Carboxymethyl Beta-Glucan, Anthemis Nobilis (Chamomile) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cassia Alata (Senna) Leaf Extract.
- Other Information
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SPL UNCLASSIFIED SECTION
SUN DROPS
Broad Spectrum SPF 50
This light-textured sun serum for the face provides intensive SPF 50 broad spectrum protection, thanks to the balanced combination of UVA and UVB filters. The serum is particularly suitable for sensitive skin.
Caution: Apply sunscreen liberally before sun exposure. Applying an insufficient amount of sunscreen will reduce the level of sun protection (i.e. the SPF) indicated. Avoid intensive midday sun. Reapply frequently in order to maintain protection, especially after perspiring, swimming or drying off with a towel. Shield babies and toddlers from direct UV radiation, dress them in protective clothing and use a sunscreen with a minimum SPF of 25. Do not overexpose yourself to the sun, even if you are using sunscreen. May cause discoloration of textiles and leather.
Barbara Sturm
Molecular Cosmetics GmbH, Dist
Königsallee 24
D-40212 Düsseldorf
www.drsturm.com
Made in the USA with foreign and domestic parts. - Packaging
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INGREDIENTS AND APPEARANCE
DR. BARBARA STURM MOLECULAR COSMETICS SPF 50 SUNSCREEN
homosalate, octinoxate, octisalate, avobenzone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83175-232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PURSLANE (UNII: M6S840WXG5) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) XANTHAN GUM (UNII: TTV12P4NEE) PENTYLENE GLYCOL (UNII: 50C1307PZG) BENZOIC ACID (UNII: 8SKN0B0MIM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) POLYSORBATE 20 (UNII: 7T1F30V5YH) PANTHENOL (UNII: WV9CM0O67Z) ARGININE (UNII: 94ZLA3W45F) SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SENNA ALATA LEAF (UNII: 4BXR6YZN92) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83175-232-30 1 in 1 CARTON 01/02/2023 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:83175-232-10 1 in 1 CARTON 01/02/2023 2 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/02/2023 Labeler - Barbara Sturm Molecular Cosmetics GmbH (507357924)
