Label: KIDS SPF50 PLUS MINERAL SUNSCREEN CONTINUOUS TOTALLY TROPICAL- zinc oxide and titanium dioxide spray
- NDC Code(s): 59062-2400-2, 59062-2400-6
- 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 June 8, 2022
If you are a consumer or patient please visit this version.
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- 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
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Warnings
For external use only
When using this product
- keep out of eyes. Rinse with water to remove.
- keep away from face to avoid breathing it
- use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
- do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
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Directions
- shake well before each use
- hold can 4-6 inches away from the skin to apply
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- do not spray directly into face. Spray on hands then apply to face.
- do not apply in windy conditions
- use in a well-ventilated area
- 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, 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, fragrance2
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 170 g Can Blister Pack Label
twin pack
tear
freekids
by babyganics®easy rub-in
SPF 50
mineral
sunscreen
totally tropicaldermatologist tested
broad spectrum SPF 50
water & sweat resistant (80 minutes)made without oxybenzone, octinoxate, parabens
Discover
which of our
ingredients
are Certified
Organic on
back panel.2 - NET WT 6 OZ (170 g) each
-
INGREDIENTS AND APPEARANCE
KIDS SPF50 PLUS MINERAL SUNSCREEN CONTINUOUS TOTALLY TROPICAL
zinc oxide and titanium dioxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-2400 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 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 3.5 g in 100 g 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:59062-2400-6 170 g in 1 CAN; Type 0: Not a Combination Product 02/01/2022 2 NDC:59062-2400-2 2 in 1 BLISTER PACK 06/01/2022 2 NDC:59062-2400-6 170 g in 1 CAN; 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 02/01/2022 Labeler - KAS Direct LLC dba BabyGanics (002764605) Establishment Name Address ID/FEI Business Operations Fruit of the Earth, Inc. 080086802 MANUFACTURE(59062-2400)