babyganics®

babyganics®
SPL v3
SPL
SPL Set ID edced0dc-dd43-4ac9-b816-f4edb45fc87b
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

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
    • 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

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

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 20%

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

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
    • 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)

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

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 20%

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


Raw Label Data

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