Babyganics®

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

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, glycerin

, helianthus annuus (sunflower) seed oil

, lsoamyl 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 236 Ml Tube Label

non

allergenic

blends in

& blocks

out

babyganics_®

SHEER BLEND

SPF 50 mineral

sunscreen

fragrance free

tear free • 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)

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, glycerin

, helianthus annuus (sunflower) seed oil

, lsoamyl 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 236 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 236 mL Tube Label)

non

allergenic

blends in

& blocks

out

babyganics_®

SHEER BLEND

SPF 50 mineral

sunscreen

fragrance free

tear free • 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)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "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": "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, glycerin , helianthus annuus (sunflower) seed oil , lsoamyl 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 - 236 mL Tube Label": "non allergenic blends in & blocks out babyganics ® SHEER BLEND SPF 50 mineral sunscreen fragrance free tear free • 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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information