OTC Medication Information: BabyGanics Sunscreen 50 SPF

BABYGANICS SUNSCREEN 50 SPF- octinoxate, octisalate and zinc oxide spray
KAS Direct LLC dba BabyGanics

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 Facts

Active ingredients

Octinoxate 7.5%, Octisalate 5.0%, Zinc oxide 11.2%

Purpose

Sunscreen

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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

protect this product from excessive heat and direct sun

Inactive ingredients

water, caprylic/capric triglyceride, glycerin, aloe barbadensis leaf juice, vp/hexadecene copolymer, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, citric acid, squalane, lecithin, polysorbate 60, sorbitan isostearate.

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL — 177 mL Bottle Label

50+
SPF

tear free

water resistant

babyganics®

mineral-based sunscreen spray

broad spectrum SPF 50+
UVA + UVB protection
water resistant (80 minutes)
non-allergenic

no: PABA, phthalates, parabens,
fragrances or nano-particles

6 FL OZ (177mL)

040-12078-01

PRINCIPAL DISPLAY PANEL -- 177 mL Bottle Label
(click image for full-size original)
BABYGANICS SUNSCREEN 50 SPF
octinoxate, octisalate, and zinc oxide spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1207
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 112 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
ALOE VERA LEAF
HEXADECYL POVIDONE
GLYCERYL MONOSTEARATE
POLYSORBATE 80
PHENYLETHYL ALCOHOL
GLYCERYL MONOCAPRYLATE
SODIUM MAGNESIUM FLUOROSILICATE
XANTHAN GUM
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
CITRIC ACID MONOHYDRATE
SQUALANE
LECITHIN, SOYBEAN
POLYSORBATE 60
SORBITAN ISOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59062-1207-1 177 mL in 1 BOTTLE, DISPENSING None
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)

Revised: 02/2020 KAS Direct LLC dba BabyGanics

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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