Babyganics®

Babyganics®
SPL v2
SPL
SPL Set ID 8a143645-3b52-4797-9b26-dc9dd63be38f
Route
TOPICAL
Published
Effective Date 2024-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Water Coco-caprylate Medium-chain Triglycerides Coconut Oil Isoamyl Laurate Magnesium Stearate Shea Butter Ethyl Esters Magnesium Sulfate, Unspecified Form Polyhydroxystearic Acid (2300 Mw) Butyloctyl Salicylate Polyglyceryl-2 Oleate Polyglyceryl-2 Stearate Propanediol Stearyl/octyldodecyl Citrate Crosspolymer Undecylenoyl Glycine Ethylhexylglycerin Glycerin Phytate Sodium Sunflower Seed Tomato Seed Oil Cranberry Seed Nigella Sativa Seed Oil Rubus Idaeus Seed Capryloyl Glycine Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01
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 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

Zinc oxide 20%

Inactive Ingredients

butyloctyl salicylate, butyrospermum parkii (shea) butter

Certified Organic Ingredient Unless otherwise specified, product not labeled as organic.
, caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil
, ethylhexylglycerin, fragrance
Product formulated with plantderived fragrance and ingredients chosen with kids in mind.
, glycerin
, helianthus annuus (sunflower) seed oil
, isoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil
, polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

Principal Display Panel 89 Ml Tube Label

non

allergenic

blends in

& blocks

out

kids

by babyganics®

SHEER BLEND

SPF 50 mineral

sunscreen

totally tropical

tear free • dermatologist tested

broad spectrum SPF 50

water resistant (80 minutes)

Discover which of our ingredients are

Certified Organic on back panel.

3 FL OZ (89 mL)

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)

Zinc oxide 20%

Inactive Ingredients (Inactive ingredients)

butyloctyl salicylate, butyrospermum parkii (shea) butter

Certified Organic Ingredient Unless otherwise specified, product not labeled as organic.
, caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil
, ethylhexylglycerin, fragrance
Product formulated with plantderived fragrance and ingredients chosen with kids in mind.
, glycerin
, helianthus annuus (sunflower) seed oil
, isoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil
, polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

Principal Display Panel 89 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 89 mL Tube Label)

non

allergenic

blends in

& blocks

out

kids

by babyganics®

SHEER BLEND

SPF 50 mineral

sunscreen

totally tropical

tear free • dermatologist tested

broad spectrum SPF 50

water resistant (80 minutes)

Discover which of our ingredients are

Certified Organic on back panel.

3 FL OZ (89 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:02.285690 · Updated: 2026-03-14T23:06:18.731306