Spf50+ Mineral Sunscreen Spray

Spf50+ Mineral Sunscreen Spray
SPL v2
SPL
SPL Set ID 08e8bc10-85d8-4215-8351-7ec12029416c
Route
TOPICAL
Published
Effective Date 2022-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (7.25 g) Titanium Dioxide (3.5 g)
Inactive Ingredients
Water Isododecane Medium-chain Triglycerides Isohexadecane Alkyl (c12-15) Benzoate Neopentyl Glycol Diheptanoate Shea Butter Ethyl Esters Safflower Oil Didecyldimonium Chloride Butyloctyl Salicylate Coco Glucoside Cetostearyl Alcohol Cetearyl Glucoside Cetearyl Olivate Sorbitan Olivate Ethylhexylglycerin Jojoba Oil Sodium Hydroxide Chlorphenesin Xanthan Gum Tocopherol Glycerin Phytate Sodium Sunflower Seed Tomato Seed Oil Cranberry Seed Nigella Sativa Seed Oil Rubus Idaeus Seed Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01
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 ifrash occurs

Section 50567-7

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

Section 50570-1

Do not useon damaged or broken skin

Warnings

For external use only

Directions
  • apply liberally and spread evenly by hand 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

Active Ingredients

Titanium dioxide 3.5%, Zinc oxide 7.25%

Inactive Ingredients

water, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil

Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.
, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin
, sodium phytate, helianthus annuus (sunflower) seed oil
, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil
, rubus idaeus (raspberry) seed oil, citric acid

Principal Display Panel 236 Ml Bottle Label

non

allergenic

tear

free

babyganics ®

SPF 50

mineral

sunscreen

pediatrician tested

broad spectrum SPF 50

water resistant (80 minutes)

made without oxybenzone, octinoxate,

parabens, fragrance, nano-particles

Discover which of our ingredients are

Certified Organic on back panel.

8 FL OZ (236 mL)

1147142

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 ifrash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally and spread evenly by hand 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

Active Ingredients (Active ingredients)

Titanium dioxide 3.5%, Zinc oxide 7.25%

Inactive Ingredients (Inactive ingredients)

water, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil

Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.
, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin
, sodium phytate, helianthus annuus (sunflower) seed oil
, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil
, rubus idaeus (raspberry) seed oil, citric acid

Principal Display Panel 236 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label)

non

allergenic

tear

free

babyganics ®

SPF 50

mineral

sunscreen

pediatrician tested

broad spectrum SPF 50

water resistant (80 minutes)

made without oxybenzone, octinoxate,

parabens, fragrance, nano-particles

Discover which of our ingredients are

Certified Organic on back panel.

8 FL OZ (236 mL)

1147142

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:51.557646 · Updated: 2026-03-14T23:04:09.079304