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
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
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 pro...
protect this product from excessive heat and direct sun
Drug Facts
Octinoxate 5.0%, Octisalate 4.0%, Zinc oxide 11.2%
Sunscreen
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
protect this product from excessive heat and direct sun
water, caprylic/capric triglyceride, glycerin, vp/hexadecene copolymer, aloe barbadensis leaf juice, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, squalane, citric acid, lecithin, polysorbate 60, sorbitan isostearate.
Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59062-1229-1 | 2020-02-05 | C162847 | 48780-1 | 9d75b9d0-6898-f424-e053-dadaa90a57ce | babyganics® Sunscreen Spray 30 SPF |
| 59062-1229-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6898-f424-e053-dadaa90a57ce | babyganics® Sunscreen Spray 30 SPF |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59062-1229-1 | BabyGanics Sunscreen 30 SPF | 177 mL in 1 BOTTLE, DISPENSING | SPRAY | 177 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59062-1229 | BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241225_391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| GLYCERYL CAPRYLATE | INACTIVE INGREDIENT | TM2TZD4G4A | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 2 | |
| HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) | INACTIVE INGREDIENT | AG75W62QYU | 2 | |
| HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) | INACTIVE INGREDIENT | 86FQE96TZ4 | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| PHENYLETHYL ALCOHOL | INACTIVE INGREDIENT | ML9LGA7468 | 2 | |
| POLYGLYCERYL-6 DIOLEATE | INACTIVE INGREDIENT | 062SZD3F3X | 2 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 2 | |
| SODIUM MAGNESIUM FLUOROSILICATE | INACTIVE INGREDIENT | U1QJ22MC8E | 2 | |
| SORBITAN ISOSTEARATE | INACTIVE INGREDIENT | 01S2G2C1E4 | 2 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59062-1229 | 59062-1229-1 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | EMULSION / TOPICAL | 0.11 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GEL / TOPICAL | 12 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LOTION / TOPICAL | 0.85 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SYSTEM / TOPICAL | 28 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / TOPICAL | 34050 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | OINTMENT / TOPICAL | 0.1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / TOPICAL | 0.98 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| GLYCERYL CAPRYLATE | GLYCERYL MONOCAPRYLATE | TM2TZD4G4A | TABLET / ORAL | 1 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | CREAM / TOPICAL | 6 %w/w | ||
| PHENYLETHYL ALCOHOL | PHENYLETHYL ALCOHOL | ML9LGA7468 | SPRAY / NASAL | 1 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | POWDER, FOR SUSPENSION / ORAL | 39 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | OINTMENT / TOPICAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LOTION / TOPICAL | 15 %w/w | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SPRAY / TOPICAL | 540 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / TOPICAL | 2.85 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LIQUID / TOPICAL | 1 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / TOPICAL | 0.98 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / TOPICAL | 0.2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / TOPICAL | 34050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | LOTION / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERYL CAPRYLATE | GLYCERYL MONOCAPRYLATE | TM2TZD4G4A | TABLET / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERYL CAPRYLATE | GLYCERYL MONOCAPRYLATE | TM2TZD4G4A | CAPSULE / ORAL | 400 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CAPSULE / ORAL | 20 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| SQUALANE | SQUALANE | GW89575KF9 | AEROSOL, FOAM / TOPICAL | 2.23 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | AEROSOL, FOAM / TOPICAL | 30 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOTION / TOPICAL | 0.3 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / TOPICAL | NA | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg |
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 Sunscreen 30 SPF | ZINC OXIDE, OCTINOXATE, AND OCTISALATE | KAS Direct LLC dba BabyGanics | 391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1 | 2024-12-19 | Warnings | 59062-1229-1 59062-1229 59062122901 288cb5ff-0e3f-40de-8e46-3424f6d03c2c 391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.