Babyganics® Sunscreen Spray 30 Spf

Babyganics® Sunscreen Spray 30 Spf
SPL v5
SPL
SPL Set ID 391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1
Route
TOPICAL
Published
Effective Date 2024-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (112 mg) Octinoxate (50 mg) Octisalate (40 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Glycerin Hexadecyl Povidone Aloe Vera Leaf Glyceryl Monostearate Polyglyceryl-6 Dioleate Polysorbate 80 Phenylethyl Alcohol Glyceryl Monocaprylate Sodium Magnesium Fluorosilicate Xanthan Gum Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Squalane Citric Acid Monohydrate Soybean Lecithin Polysorbate 60 Sorbitan Isostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-06-21 Until 2026-12-31
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

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

Active Ingredients

Octinoxate 5.0%, Octisalate 4.0%, Zinc oxide 11.2%

Inactive Ingredients

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

Principal Display Panel 177 Ml Bottle Label

30

SPF

tear

free

water

resistant

babyganics®

mineral-based

sunscreen spray

broad spectrum SPF 30

UVA + UVB protection

water resistant (80 minutes)

non-allergenic

no: PABA, phthalates, parabens,

fragrances or nano-particles

6 FL OZ (177mL)

040-12290-01

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

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 (Other information)

protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Octinoxate 5.0%, Octisalate 4.0%, Zinc oxide 11.2%

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 177 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label)

30

SPF

tear

free

water

resistant

babyganics®

mineral-based

sunscreen spray

broad spectrum SPF 30

UVA + UVB protection

water resistant (80 minutes)

non-allergenic

no: PABA, phthalates, parabens,

fragrances or nano-particles

6 FL OZ (177mL)

040-12290-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:01.221184 · Updated: 2026-03-14T23:06:18.731306