Label: SPF50 PLUS MINERAL SUNSCREEN- zinc oxide and titanium dioxide spray
- NDC Code(s): 59062-2210-6, 59062-2210-8
- 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 March 15, 2022
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
-
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 and spread evenly by hand 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- do not spray directly into face. Spray on hands then apply to face.
- 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
-
Inactive ingredients
water, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil1, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin1, sodium phytate, helianthus annuus (sunflower) seed oil1, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, citric acid
- 1
- Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
non
allergenictear
freebabyganics®
SPF 50
mineral
sunscreenpediatrician tested
broad spectrum SPF 50
water resistant (80 minutes)made without oxybenzone, octinoxate,
parabens, fragrance, nano-particlesDiscover which of our ingredients are
Certified Organic on back panel.8 FL OZ (236 mL)
1147142
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INGREDIENTS AND APPEARANCE
SPF50 PLUS MINERAL SUNSCREEN
zinc oxide and titanium dioxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-2210 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.25 g in 100 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 3.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOHEXADECANE (UNII: 918X1OUF1E) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) SAFFLOWER OIL (UNII: 65UEH262IS) DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Coco Glucoside (UNII: ICS790225B) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Cetearyl Glucoside (UNII: 09FUA47KNA) Cetearyl Olivate (UNII: 58B69Q84JO) Sorbitan Olivate (UNII: MDL271E3GR) Ethylhexylglycerin (UNII: 147D247K3P) JOJOBA OIL (UNII: 724GKU717M) Sodium Hydroxide (UNII: 55X04QC32I) Chlorphenesin (UNII: I670DAL4SZ) Xanthan Gum (UNII: TTV12P4NEE) Tocopherol (UNII: R0ZB2556P8) Glycerin (UNII: PDC6A3C0OX) PHYTATE SODIUM (UNII: 88496G1ERL) SUNFLOWER SEED (UNII: R9N3379M4Z) TOMATO SEED OIL (UNII: 7N87T9C06T) CRANBERRY SEED (UNII: 38ZFO1X2U7) NIGELLA SATIVA SEED OIL (UNII: CS4U38E731) RUBUS IDAEUS SEED (UNII: M3CL7US2ZG) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-2210-6 170 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/01/2022 2 NDC:59062-2210-8 236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2022 Labeler - KAS Direct LLC dba BabyGanics (002764605) Establishment Name Address ID/FEI Business Operations Fruit of the Earth, Inc. 080086802 MANUFACTURE(59062-2210)