Label: SPF 50 PLUS SUNSCREEN- titanium dioxide, octisalate, and zinc oxide lotion
- NDC Code(s): 59062-1000-1, 59062-1000-2, 59062-1000-6, 59062-1000-8
- 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 July 15, 2020
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 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
-
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, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil1, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil1, glycerin1, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter1, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol
- 1
- Certified Organic Ingredient
Unless otherwise specified, product not labeled as organic
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 177 mL Tube Label
50+
SPFtear
freewater
resistantbabyganics
SPF 50+
sunscreen
lotionbroad spectrum SPF 50+
UVA + UVB protection
water resistant (80 minutes)
non-allergenic • pediatrician
& dermatologist testedformulated with: Zinc Oxide,
Octisalate, Titanium Dioxide*formulated without: PABA
phthalates • parabens
fragrances • nano-particlesDiscover which of our
ingredients are Certified
Organic on back panel.6 FL OZ (177mL)
-
INGREDIENTS AND APPEARANCE
SPF 50 PLUS SUNSCREEN
titanium dioxide, octisalate, and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK) Polyglyceryl-2 Stearate (UNII: 253MC0P0YV) CETYL ALCOHOL (UNII: 936JST6JCN) Jojoba Oil (UNII: 724GKU717M) Glyceryl Monostearate (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) Coconut Oil (UNII: Q9L0O73W7L) Tomato Seed Oil (UNII: 7N87T9C06T) Sunflower Oil (UNII: 3W1JG795YI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Cranberry Seed Oil (UNII: 73KDS3BW5E) Nigella Sativa Seed Oil (UNII: CS4U38E731) Raspberry Seed Oil (UNII: 9S8867952A) PHENOXYETHANOL (UNII: HIE492ZZ3T) XANTHAN GUM (UNII: TTV12P4NEE) Shea Butter (UNII: K49155WL9Y) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) Stearyl Alcohol (UNII: 2KR89I4H1Y) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Docosanol (UNII: 9G1OE216XY) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) Silicon Dioxide (UNII: ETJ7Z6XBU4) Aluminum Oxide (UNII: LMI26O6933) Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-1000-2 59 mL in 1 TUBE; Type 0: Not a Combination Product 07/24/2017 2 NDC:59062-1000-6 177 mL in 1 TUBE; Type 0: Not a Combination Product 07/24/2017 3 NDC:59062-1000-8 236 mL in 1 TUBE; Type 0: Not a Combination Product 07/24/2017 4 NDC:59062-1000-1 354 mL in 1 TUBE; Type 0: Not a Combination Product 07/24/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 07/24/2017 Labeler - KAS Direct LLC dba BabyGanics (002764605)