Label: OUTDOOR ESSENTIALS- zinc oxide, octocrylene, and octisalate kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 59062-0120-6, 59062-5400-1 - Packager: KAS Direct LLC dba BabyGanics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
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
-
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
-
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
-
PRINCIPAL DISPLAY PANEL - Kit Carton
outdoor essentials
babyganics
SPF 50+
sunscreen spray
broad spectrum SPF 50+
UVA + UVB protection ∙ non-allergenic
water resistant (80 minutes)natural
insect repellent
plant and essential oils help keep
mosquitoes awayDiscover which of our ingredients are Certified Organic on back panel.
6 FL OZ (177 mL)
6 FL OZ (177 mL)
-
INGREDIENTS AND APPEARANCE
OUTDOOR ESSENTIALS
zinc oxide, octocrylene, and octisalate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-5400 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-5400-1 1 in 1 PACKAGE 01/01/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, SPRAY 177 mL Part 2 1 BOTTLE, SPRAY 177 mL Part 1 of 2 BABYGANICS SPF 50 PLUS SUNSCREEN
zinc oxide, octisalate, and octocrylene sprayProduct Information Item Code (Source) NDC:59062-0120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 112 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) LAPONITE (UNII: D703131383) XANTHAN GUM (UNII: TTV12P4NEE) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SQUALANE (UNII: GW89575KF9) TOMATO SEED OIL (UNII: 7N87T9C06T) SUNFLOWER OIL (UNII: 3W1JG795YI) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSORBATE 60 (UNII: CAL22UVI4M) ALOE VERA LEAF (UNII: ZY81Z83H0X) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) RASPBERRY SEED OIL (UNII: 9S8867952A) NIGELLA SATIVA SEED OIL (UNII: CS4U38E731) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-0120-6 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2019 Part 2 of 2 NATURAL INSECT REPELLENT
lotions, oils, powders, and creams sprayProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR SOYBEAN OIL (UNII: 241ATL177A) INGR ROSEMARY OIL (UNII: 8LGU7VM393) INGR CITRONELLA OIL (UNII: QYO8Q067D0) INGR GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) INGR JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) INGR PEPPERMINT OIL (UNII: AV092KU4JH) INGR WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2020 Labeler - KAS Direct LLC dba BabyGanics (002764605)