babyganics spf 50+ sunscreen spray

babyganics spf 50+ sunscreen spray
SPL v4
SPL
SPL Set ID 4075f9dc-c25f-434f-a3fc-a7f896295c3d
Route
topical
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (112 mg) octisalate (50 mg) octocrylene (60 mg)
Inactive Ingredients
water medium-chain triglycerides glycerin butyloctyl salicylate glyceryl monostearate polysorbate 80 phenylethyl alcohol glyceryl monocaprylate laponite xanthan gum hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) citric acid monohydrate squalane tomato seed oil sunflower oil soybean lecithin polysorbate 60 aloe vera leaf cranberry seed oil raspberry seed oil nigella sativa seed oil sorbitan isostearate

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2019-07-01 Until 2026-12-31

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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
  • do not spray directly into face. Spray on hands then apply to face.
  • 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, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid

Description

Drug Facts

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

Active Ingredients

Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%

Principal Display Panel 177 Ml Bottle Label

50+

SPF

tear

free

water

resistant

babyganics

SPF 50+

sunscreen

spray

broad spectrum SPF 50+

UVA + UVB protection

water resistant (80 minutes)

non-allergenic • pediatrician &

dermatologist tested

formulated with: Zinc Oxide,

Octocrylene, Octisalate*

formulated without: PABA

phthalates • parabens

fragrances • nano-particles

Discover which of our

ingredients are Certified

Organic on back panel.

6 FL OZ (177 mL)

040-12078-B02


Structured Label Content

Warnings

For external use only

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
Purpose

Sunscreen

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
  • do not spray directly into face. Spray on hands then apply to face.
  • 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

Inactive Ingredients (Inactive ingredients)

water, caprylic/capric triglyceride, glycerin, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid

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

Active Ingredients (Active ingredients)

Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%

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

50+

SPF

tear

free

water

resistant

babyganics

SPF 50+

sunscreen

spray

broad spectrum SPF 50+

UVA + UVB protection

water resistant (80 minutes)

non-allergenic • pediatrician &

dermatologist tested

formulated with: Zinc Oxide,

Octocrylene, Octisalate*

formulated without: PABA

phthalates • parabens

fragrances • nano-particles

Discover which of our

ingredients are Certified

Organic on back panel.

6 FL OZ (177 mL)

040-12078-B02


Advanced Ingredient Data


Raw Label Data

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