Label: SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS- titanium dioxide and zinc oxide stick
KIDS SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS- titanium dioxide and zinc oxide stick
- NDC Code(s): 59062-1200-1, 59062-1200-2, 59062-2200-4
- 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.
- 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
-
Directions
- apply liberally and evenly 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- this product is meant for targeted protection and small areas of exposed skin
- for full protection use in conjunction with another sunscreen lotion or spray
- 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
C12-15 alkyl benzoate, caprylic/capric triglyceride, beeswax1, copernicia cerifera (carnauba) wax1, neopentyl glycol diethylhexanoate, tribehenin, euphorbia cerifera (candelilla) wax, PPG-3 benzyl ether myristate, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, helianthus annuus (sunflower) seed wax, myristyl myristate, stearyl/octadodecyl citrate crosspolymer, simmondsia chinensis (jojoba) seed oil1, polyglyceryl-10 pentaoleate, jojoba esters, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, polyhydroxystearic acid, caprylyl glycol, ethylhexylglycerin, silica, alumina
- 1
- Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 13 g Applicator Blister Pack
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PRINCIPAL DISPLAY PANEL - 45.5 g Applicator Label
50+
SPFbabyganics
kids
SPF 50+ sunscreen stick
all mineral active ingredientsbroad spectrum SPF 50+
UVA + UVB protection
non-allergenic • water &
sweat resistant (80 minutes)
tear free • pediatrician &
dermatologist testedformulated with: Titanium
Dioxide, Zinc Oxide*formulated without: PABA
phthalates • parabens
fragrances • nano-particlesDiscover which of our
ingredients are Certified
Organic on back panel.Net. Wt. 1.6 OZ (45.5 g)
040-17936-B01
-
INGREDIENTS AND APPEARANCE
SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS
titanium dioxide and zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 79 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 67 mg in 1 g Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) TRIBEHENIN (UNII: 8OC9U7TQZ0) CANDELILLA WAX (UNII: WL0328HX19) PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK) JOJOBA OIL (UNII: 724GKU717M) Polyglyceryl-10 Pentaoleate (UNII: BH1TF96DJC) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) RASPBERRY SEED OIL (UNII: 9S8867952A) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) SUNFLOWER OIL (UNII: 3W1JG795YI) TOMATO SEED OIL (UNII: 7N87T9C06T) NIGELLA SATIVA SEED OIL (UNII: CS4U38E731) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Silicon Dioxide (UNII: ETJ7Z6XBU4) Aluminum Oxide (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-1200-1 1 in 1 BLISTER PACK 06/21/2013 1 13 g in 1 APPLICATOR; Type 0: Not a Combination Product 2 NDC:59062-1200-2 2 in 1 BLISTER PACK 06/21/2013 2 13 g in 1 APPLICATOR; 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 06/21/2013 KIDS SPF 50 PLUS SUNSCREEN ALL MINERAL ACTIVE INGREDIENTS
titanium dioxide and zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-2200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 79 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 67 mg in 1 g Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) TRIBEHENIN (UNII: 8OC9U7TQZ0) CANDELILLA WAX (UNII: WL0328HX19) PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK) JOJOBA OIL (UNII: 724GKU717M) Polyglyceryl-10 Pentaoleate (UNII: BH1TF96DJC) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) RASPBERRY SEED OIL (UNII: 9S8867952A) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) SUNFLOWER OIL (UNII: 3W1JG795YI) TOMATO SEED OIL (UNII: 7N87T9C06T) NIGELLA SATIVA SEED OIL (UNII: CS4U38E731) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Silicon Dioxide (UNII: ETJ7Z6XBU4) Aluminum Oxide (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-2200-4 45.5 g in 1 APPLICATOR; Type 0: Not a Combination Product 06/21/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/21/2013 Labeler - KAS Direct LLC dba BabyGanics (002764605)