Indications and 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
BABYGANICS SPF 50+ SUNSCREEN SPRAY
- Manufacturer
- KAS Direct LLC dba Babyganics
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:48:24
Label at a glance#
ProductBABYGANICS SPF 50 Plus SUNSCREEN
Active ingredientZINC OXIDE, OCTISALATE, OCTOCRYLENE
Label structure10 sections
Dosage and administration
apply liberally 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 sunscre...
Storage and handling
protect this product from excessive heat and direct sun
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients
Zinc Oxide 11.20%, Octocrylene 6.0%, Octisalate 5.0%
Purpose
Sunscreen
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
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
- 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
Inactive ingredients
water, caprylic/capric triglyceride, glycerin, butyloctyl salicylate, stearyl/octyldodecyl citrate crosspolymer, aloe barbadensis leaf juice, glyceryl stearate, polyglyceryl-6 polyricinoleate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, lecithin, polysorbate 60, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil organic, rubus idaeus (raspberry) seed oil, squalane, xanthan gum, polysorbate 80, phenethyl alcohol, glyceryl caprylate, lithium magnesium sodium silicate, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, sorbitan isostearate, citric acid
SPL UNCLASSIFIED SECTION
dist. by KAS Direct, LLC.
Westbury, NY 11590
PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
50+
SPF
tear
free
water
resistant
babyganics
SPF 50+
sunscreen
spray
broad spectrum SPF 50+
UVA + UVB protection
water resistant (80 minutes)
non-allergenic • pediatrician &
dermatologist tested
formulated with: Zinc Oxide,
Octocrylene, Octisalate*
formulated without: PABA
phthalates • parabens
fragrances • nano-particles
Discover which of our
ingredients are Certified
Organic on back panel.
6 FL OZ (177 mL)
040-12078-B02
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59062-0120-1 | BABYGANICS SPF 50 Plus SUNSCREEN | 177 mL in 1 BOTTLE, DISPENSING | SPRAY | 177 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59062-0120 | BABYGANICS SPF 50 PLUS SUNSCREEN (ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE) SPRAY [KAS DIRECT LLC DBA BABYGANICS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241225_4075f9dc-c25f-434f-a3fc-a7f896295c3d.zip |
Products#
Every source-derived product name is available through these pages.
- BABYGANICS SPF 50 Plus SUNSCREEN
- ZINC OXIDE, OCTISALATE, and OCTOCRYLENE
- ZINC OXIDE
- OCTISALATE
- OCTOCRYLENE
- WATER
- MEDIUM-CHAIN TRIGLYCERIDES
- GLYCERIN
- BUTYLOCTYL SALICYLATE
- GLYCERYL MONOSTEARATE
- POLYSORBATE 80
- PHENYLETHYL ALCOHOL
- GLYCERYL MONOCAPRYLATE
- LAPONITE
- XANTHAN GUM
- HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
- CITRIC ACID MONOHYDRATE
- SQUALANE
- TOMATO SEED OIL
- SUNFLOWER OIL
- SOYBEAN LECITHIN
- POLYSORBATE 60
- ALOE VERA LEAF
- CRANBERRY SEED OIL
- RASPBERRY SEED OIL
- NIGELLA SATIVA SEED OIL
- SORBITAN ISOSTEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59062-0120 | 59062-0120-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BABYGANICS SPF 50 Plus SUNSCREEN | ZINC OXIDE, OCTISALATE, AND OCTOCRYLENE | KAS Direct LLC dba Babyganics | 4075f9dc-c25f-434f-a3fc-a7f896295c3d | 2024-12-20 | Warnings | 59062-0120-1 59062-0120 59062012001 0bd9880a-6b33-495b-a58e-7a5e65cbac4a 4075f9dc-c25f-434f-a3fc-a7f896295c3d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.