Kids Spf50+ Mineral Sunscreen Rollerball Totally Tropical

Kids Spf50+ Mineral Sunscreen Rollerball Totally Tropical
SPL v3
SPL
SPL Set ID d3bdda65-bcb4-42d9-84af-d14c7f4421bd
Route
TOPICAL
Published
Effective Date 2024-12-23
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 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 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
  • 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

, 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, fragrance
Product formulated with plant-derived fragrance and ingredients chosen with kids in mind. Learn about these and all our ingredients and the choices we make at babyganics.com/products

Principal Display Panel 88 Ml Bottle Label

tear

free

roll

on

kids

by babyganics®

easy rub-in

SPF 50

mineral

sunscreen

totally tropical

dermatologist tested

broad spectrum SPF 50

water & sweat resistant (80 minutes)

Discover which of our ingredients are

Certified Organic on back panel.

3 FL OZ (88 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 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
  • 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

, 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, fragrance
Product formulated with plant-derived fragrance and ingredients chosen with kids in mind. Learn about these and all our ingredients and the choices we make at babyganics.com/products

Principal Display Panel 88 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label)

tear

free

roll

on

kids

by babyganics®

easy rub-in

SPF 50

mineral

sunscreen

totally tropical

dermatologist tested

broad spectrum SPF 50

water & sweat resistant (80 minutes)

Discover which of our ingredients are

Certified Organic on back panel.

3 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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