Label: SPF 50 MINERAL SUNSCREEN BABYGANICS- titanium dioxide and zinc oxide lotion
SPF 50 MINERAL SUNSCREEN BKIDS- titanium dioxide and zinc oxide lotion
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NDC Code(s):
59062-1001-2,
59062-1001-6,
59062-1001-8,
59062-1101-2, view more59062-1101-6
- Packager: KAS Direct LLC dba BabyGanics
- 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 February 22, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: ask a doctor
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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 a Broad Spectrum SPF value 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- sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
water, ethylhexyl palmitate, butyloctyl salicylate, caprylic/capric triglyceride, trimethylpentanediol/adipic acid/glycerin crosspolymer, cetearyl olivate, glycerin, sorbitan olivate, tocopheryl acetate, phenoxyethanol, cetearyl alcohol, cetearyl glucoside, propanediol, alumina, xanthan gum, jojoba esters, 1,2-hexanediol, bisabolol, helianthus annuus (sunflower) seed oil1, solanum lycopersicum (tomato) seed oil, lecithin, polyhydroxystearic acid, caprylhydroxamic acid, citric acid, isopropyl myristate, isostearic acid, polyglyceryl-3 polyricinoleate, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil
- 1
- Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic • *Learn about these and all our ingredients and the choices we make at babyganics.com/products
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 59 mL Tube Label - 59062-1001
- PRINCIPAL DISPLAY PANEL - 59 mL Tube Label - 59062-1101
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INGREDIENTS AND APPEARANCE
SPF 50 MINERAL SUNSCREEN BABYGANICS
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 31.6 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Ethylhexyl Palmitate (UNII: 2865993309) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) Cetearyl Olivate (UNII: 58B69Q84JO) GLYCERIN (UNII: PDC6A3C0OX) Sorbitan Olivate (UNII: MDL271E3GR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Propanediol (UNII: 5965N8W85T) ALUMINUM OXIDE (UNII: LMI26O6933) XANTHAN GUM (UNII: TTV12P4NEE) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) 1,2-Hexanediol (UNII: TR046Y3K1G) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) SUNFLOWER OIL (UNII: 3W1JG795YI) TOMATO SEED OIL (UNII: 7N87T9C06T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Caprylhydroxamic Acid (UNII: UPY805K99W) Isopropyl Myristate (UNII: 0RE8K4LNJS) Isostearic Acid (UNII: X33R8U0062) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) Nigella Sativa Seed Oil (UNII: CS4U38E731) RASPBERRY SEED OIL (UNII: 9S8867952A) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-1001-2 59 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2021 2 NDC:59062-1001-6 177 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2021 3 NDC:59062-1001-8 226 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2021 SPF 50 MINERAL SUNSCREEN BKIDS
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 31.6 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Ethylhexyl Palmitate (UNII: 2865993309) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) Cetearyl Olivate (UNII: 58B69Q84JO) GLYCERIN (UNII: PDC6A3C0OX) Sorbitan Olivate (UNII: MDL271E3GR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Propanediol (UNII: 5965N8W85T) ALUMINUM OXIDE (UNII: LMI26O6933) XANTHAN GUM (UNII: TTV12P4NEE) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) 1,2-Hexanediol (UNII: TR046Y3K1G) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) SUNFLOWER OIL (UNII: 3W1JG795YI) TOMATO SEED OIL (UNII: 7N87T9C06T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Caprylhydroxamic Acid (UNII: UPY805K99W) Isopropyl Myristate (UNII: 0RE8K4LNJS) Isostearic Acid (UNII: X33R8U0062) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) Nigella Sativa Seed Oil (UNII: CS4U38E731) RASPBERRY SEED OIL (UNII: 9S8867952A) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-1101-2 59 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2021 2 NDC:59062-1101-6 177 mL in 1 TUBE; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2021 Labeler - KAS Direct LLC dba BabyGanics (002764605) Establishment Name Address ID/FEI Business Operations Autumn Harp 064187883 MANUFACTURE(59062-1001, 59062-1101) , LABEL(59062-1001, 59062-1101)
